Latest Articles
If it’s your first time on this website, please read the disclaimer section.
Oct 12 – Oct 19, 2026
Nivolumab-Ipilimumab for Localized Microsatellite Instability-High Gastric/Gastroesophageal Junction Adenocarcinoma: The Phase 2 NEONIPIGA Nonrandomized Clinical Trial.
JAMA ONCOL · Q1 JOURNAL - RANK #14/326TOP-TIER
The NEONIPIGA phase 2 nonrandomized clinical trial evaluated neoadjuvant nivolumab plus ipilimumab followed by surgery and adjuvant nivolumab in 32 patients with localized deficient mismatch repair/microsatellite instability-high gastric or gastroesophageal junction adenocarcinoma. The primary end point of pathological complete response was previously reported; this analysis reports long-term secondary outcomes with a median follow-up of 48.3 months. Among 32 patients in the intention-to-treat population, 4-year overall survival was 84.1%, and in 31 patients eligible for surgery, 4-year event-free survival was 83.5%; 17 of 29 patients (59%) achieved pathological complete response. The immunotherapy regimen was associated with sustained long-term survival, but no clear evidence of improved survival over surgery alone was observed.
10.1001/jamaoncol.2026.4162
Neoadjuvant Stereotactic Ablative Radiotherapy Before Inferior Vena Cava Thrombectomy for Renal Cell Carcinoma: A Phase 2 Nonrandomized Clinical Trial.
JAMA ONCOL · Q1 JOURNAL - RANK #14/326TOP-TIER
This single-center phase 2 nonrandomized trial evaluated neoadjuvant stereotactic ablative radiotherapy (SABR) before nephrectomy and inferior vena cava thrombectomy in 23 patients with renal cell carcinoma and Mayo level II-IV tumor thrombus. SABR delivered 40 Gy in 5 fractions or 36 Gy in 3 fractions, followed by surgery in 22 patients, with 21 included in the primary analysis. One-year recurrence-free survival was 71.4% (95% CI, 47.2-86.0), meeting the prespecified benchmark of 55.7% (P=.09); one-year overall and cancer-specific survival were both 95.2%. The authors concluded that neoadjuvant SABR appeared feasible with acceptable safety, though recurrence-free survival results remain exploratory and warrant further evaluation.
10.1001/jamaoncol.2026.4172
Anti-TNFR2 antibody BI-1808 induces tumor regression and antitumor T cell immunity through T reg and myeloid cell modulation in patients with solid tumors.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This study clinically evaluated the safety, pharmacodynamic biomarkers, and efficacy of BI-1808, a first-in-class anti-TNFR2 antibody, as a novel immunotherapy for solid tumors. Preclinical modeling informed a first-in-human phase 1 dose-escalation trial in patients with solid cancers. BI-1808 was safe and well-tolerated, achieved full receptor occupancy, and induced tumor regression in two patients (non-small cell lung cancer and gastrointestinal sarcoma), with stable disease in 6 of 21 evaluable patients. Pharmacodynamic analyses confirmed dose-dependent regulatory T cell reduction, monocyte activation, and CD8+ T-cell activation, supporting further development of this mechanistically distinct immunotherapy.
10.1158/1078-0432.CCR-26-2049
Ponatinib-Blinatumomab or Imatinib-Chemotherapy for Adult Ph-Positive ALL.
NEW ENGL J MED · Q1 JOURNAL - RANK #2/332TOP-TIER
This randomized phase 3 trial evaluated ponatinib plus blinatumomab versus imatinib plus chemotherapy as frontline treatment for adult Philadelphia-positive acute lymphoblastic leukemia. A total of 236 patients were randomized 2:1 to the intervention (n=158) or control (n=78) group, with crossover permitted for control patients with persistent or recurrent measurable residual disease. At a median follow-up of 23.7 months, 24-month event-free survival was 86% versus 67% (P<0.001), and molecular response rates after consolidation were 71% versus 49%, favoring the chemotherapy-free regimen. The authors concluded that the frontline chemotherapy-free targeted and immunotherapeutic approach was superior to imatinib plus chemotherapy.
10.1056/NEJMoa2606208
Dose-Escalated Focal Salvage High-Dose-Rate Brachytherapy and Genomic Classifier Risk Stratification in Radiorecurrent Prostate Cancer: The F-SHARP Phase I/II Clinical Trial.
J CLIN ONCOL · Q1 JOURNAL - RANK #6/326TOP-TIER
F-SHARP is a multi-institutional phase I/II prospective clinical trial evaluating dose-escalated focal salvage high-dose-rate brachytherapy (DE-fsHDR) in 62 patients with intraprostatic radiorecurrence after definitive radiotherapy for localized prostate cancer. Patients received up to 30 Gy in one or two fractions, with the primary endpoint of acute grade ≥3 genitourinary and gastrointestinal toxicity and secondary endpoints including quality of life, disease control, and genomic classifier (GC) risk stratification via a clinical-grade transcriptome assay. No acute grade 3 toxicities occurred and two patients (3.2%) had late grade 3 toxicity; three-year survival rates were 62.7% (bPFS), 67.5% (rPFS), 73.0% (LRFS), and 85.9% (MFS), with no differences between fractionation groups. Among 31 patients with GC results, higher scores were associated with worse bPFS, rPFS, LRFS, and MFS, and all four patients with GC score >0.85 experienced recurrence. The authors conclude that DE-fsHDR is a safe and effective salvage treatment for intraprostatic radiorecurrence and that GC score is a promising prognostic tool warranting further study to guide treatment intensification.
10.1200/JCO-25-02730
Immune biomarkers of response and resistance to ipilimumab and nivolumab in metastatic castration-resistant prostate cancer.
SCI ADV · Q1 JOURNAL - RANK #12/135TOP-TIER
The AMADEUS prostate expansion cohort (NCT03651271) is a prospective clinical trial evaluating escalating ipilimumab doses combined with nivolumab in 32 patients with metastatic castration-resistant prostate cancer. Coprimary endpoints were 6-month disease control rate (DCR) and changes in tumoral CD8 percentage, with DCRs of 33% (4/12) for I1+N360, 20% (1/5) for I3+N1, and 20% (3/15) for I5+N1, and a median tumoral CD8 increase of 5.0%. Higher ipilimumab doses were tolerable, but I1+N360 achieved similar disease control and immune activation with a more favorable safety profile. Early progression correlated with a TREM2-associated myeloid gene signature, also enriched in two independent prostate cancer datasets.
10.1126/sciadv.aee8730
Efficacy and Safety of Fruquintinib Plus TAS-102 in Patients With Previously Treated Metastatic Colorectal Cancer: Results From a Single-Arm, Multi-Center, Phase II Study.
MEDCOMM · Q1 JOURNAL - RANK #14/195TOP-TIER
This prospective, multicenter, single-arm phase II trial evaluated fruquintinib plus TAS-102 in 50 patients with previously treated metastatic colorectal cancer who had failed at least two standard therapies. With a median follow-up of 25.1 months, the median progression-free survival was 6.07 months (95% CI: 4.07-7.87) and median overall survival was 14.10 months (95% CI: 9.84-23.28), with an objective response rate of 10.0% and disease control rate of 66.0%. All patients experienced treatment-related adverse events, with 68.0% having grade ≥3 events, but no serious adverse events or deaths were reported. The authors concluded that fruquintinib plus TAS-102 demonstrated preliminary anti-tumor activity with a manageable safety profile in refractory metastatic colorectal cancer.
10.1002/mco2.71070
Toripalimab combined with chemotherapy in the treatment of primary tracheal squamous cell carcinoma: a phase II proof-of-concept study.
TRANSL LUNG CANCER R · Q1 JOURNAL - RANK #26/108
This phase II proof-of-concept study evaluated first-line toripalimab plus platinum-based chemotherapy in six patients with initially unresectable locally-advanced tracheal squamous cell carcinoma. Patients received toripalimab 240 mg with chemotherapy for 4 cycles, with tumor re-evaluation after 2 cycles to determine subsequent tracheal resection or continued immunochemotherapy and consolidation radiotherapy. All patients experienced grade 1 TRAEs (fatigue 100%), with no serious TRAEs, and clinical down-staging occurred in all six patients with a radiologic complete response rate of 33.3%. The authors concluded that this regimen showed potential efficacy with tolerable safety, enabling surgical conversion in two patients, though further studies are needed.
10.21037/tlcr-2026-0773
Effects of adjunctive metformin on recurrence-free survival and reproductive outcomes following progestin-based fertility-sparing treatment for endometrial neoplasia: Results from the FELICIA trial, a prospective, randomized, phase IIb trial with blinded central adjudication.
GYNECOL ONCOL · Q1 JOURNAL - RANK #11/140
This multicenter, open-label, randomized, phase IIb trial evaluated whether adding metformin to medroxyprogesterone acetate (MPA) improves outcomes in women with atypical endometrial hyperplasia or presumed stage IA grade 1 endometrioid carcinoma undergoing fertility-sparing treatment. A total of 154 women were randomized 1:1:1 to MPA alone, MPA plus metformin 750 mg/day, or MPA plus metformin 1500 mg/day, with blinded central adjudication of remission and recurrence. The 3-year recurrence-free survival rates were 44.7% with MPA alone and 44.5% with pooled metformin groups (P=0.825), while remission rates were 54.0%, 58.8%, and 50.9%, respectively. The authors concluded that adding metformin did not improve recurrence-free survival or remission rates, suggesting limited benefit in this fertility-sparing setting.
10.1016/j.ygyno.2026.10.004
Perioperative Camrelizumab and Apatinib for High-Risk Resectable Hepatocellular Carcinoma: A Phase II Study.
MEDCOMM · Q1 JOURNAL - RANK #14/195TOP-TIER
This single-arm phase II trial evaluated perioperative camrelizumab plus apatinib in 31 patients with high-risk resectable hepatocellular carcinoma, administering four neoadjuvant cycles followed by surgical resection and up to one year of adjuvant therapy. The primary endpoint was major pathological response (MPR), achieved in 46.2% of the 26 patients who underwent surgery, with median disease-free survival of 24.1 months and median progression-free survival of 18.3 months. Grade 3 or higher adverse events occurred in 12.9% of patients during the neoadjuvant phase. The authors concluded that this perioperative regimen demonstrated promising efficacy and manageable safety in this high-risk resectable HCC population.
10.1002/mco2.70861
Personalized neoantigen-targeting cancer vaccines in ovarian cancer: a phase 1 trial.
NAT MED · Q1 JOURNAL - RANK #1/195TOP-TIER
This phase 1 clinical trial evaluated the feasibility and safety of personalized neoantigen-targeting cancer vaccines (NeoVax) combined with delayed anti-PD-1 antibody in ten patients with high-grade epithelial ovarian cancer following standard platinum doublet chemotherapy. The study enrolled one newly diagnosed patient (Cohort A) and nine patients at first recurrence (Cohort B), with vaccination achieved in 9 of 12 evaluable Cohort B patients (75%, 90% CI 47-93%) and 1 of 9 Cohort A patients (11%, 90% CI 0.6-43%). No unexpected safety signals occurred and no patients discontinued due to toxicity, while biomarker analysis suggested biologic activity in six of ten patients associated with broader tumor and vaccine-specific immune responses. The authors conclude that the interplay between tumor antigen repertoire and induced immunity breadth appeared to dictate clinical efficacy following vaccination, with resistant tumor clones showing diverse antigen presentation mechanisms indicative of immune-selective pressure.
10.1038/s41591-026-04717-8
Talazoparib plus enzalutamide in high-volume metastatic hormone-naive prostate cancer: a randomized phase 2 trial.
NAT MED · Q1 JOURNAL - RANK #1/195TOP-TIER
This randomized phase 2 trial evaluated talazoparib plus enzalutamide versus enzalutamide alone in 54 men with high-volume metastatic hormone-naive prostate cancer, using a 1:2 randomization after two cycles of enzalutamide lead-in. The combination arm achieved a 73% PSA <0.2 ng/ml response rate at 12 months (95% CI 56-86%), exceeding the prespecified efficacy threshold (P<0.001), while the control arm showed 64.7% (95% CI 38-86%, P=0.54). Grade ≥3 adverse events occurred in 68% of combination patients versus 35% with enzalutamide alone, including two fatal myeloid neoplasms. The authors concluded that talazoparib plus enzalutamide demonstrated clinical activity but did not establish clear additional benefit over enzalutamide alone in this biomarker-unselected population, with increased toxicity.
10.1038/s41591-026-04671-5
A randomized, placebo-controlled, phase II study of docetaxel and platinum with or without erlotinib in recurrent/metastatic head and neck squamous-cell carcinomas.
ESMO OPEN · Q1 JOURNAL - RANK #36/326
This randomized, placebo-controlled, double-blind, single-center phase II trial evaluated whether adding erlotinib to platinum/docetaxel improves outcomes in first-line recurrent or metastatic head and neck squamous-cell carcinoma. A total of 120 patients were randomized 1:1 to receive platinum plus docetaxel with either erlotinib or placebo. Median progression-free survival was 6.1 versus 4.4 months (HR 0.63, 95% CI 0.42–0.95, P = 0.026), and median overall survival was 17.0 versus 13.7 months (HR 0.67, 95% CI 0.43–1.04, P = 0.0718). The study met its primary endpoint, with increased grade 2–4 adverse events but no unexpected safety signals.
10.1016/j.esmoop.2026.108584
DNA-Based Biomarkers as Predictors of Carboplatin Response in Neoadjuvant Treatment for Hormone Receptor Positive and Triple-Negative Breast Cancer.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This prospective, randomized neoadjuvant trial evaluated DNA-based biomarkers for predicting carboplatin response in 187 patients with early, high-risk, HER2-negative breast cancer, using whole-exome sequencing to calculate CAAI, LOH fraction, and HRD status before treatment with paclitaxel ± carboplatin followed by epirubicin/cyclophosphamide. Among TNBC patients, pCR was 69% (24/35) with carboplatin versus 43% (16/37) without (p=0.036), and carboplatin significantly prolonged event-free survival (p=0.017), with low genomic LOH fraction identifying those with improved EFS (p=0.007). In HR+BC patients, pCR was 15% (9/60) versus 11% (6/55; p=0.59), but low residual cancer burden increased from 16% to 35% (p=0.033), and HRD-positive tumors showed higher pCR (5/8) than HRD-negative (4/47; p=0.002). The study concludes that DNA-based biomarkers have distinct predictive values across breast cancer subtypes, with low LOH fraction guiding carboplatin use in TNBC and HRD in HR+BC.
10.1158/1078-0432.CCR-26-2212
Blood-based biomarkers in patients with recurrent, persistent, or metastatic endometrial cancer treated with olaparib and cediranib: Results from NRG-GY012.
CANCER-AM CANCER SOC · Q1 JOURNAL - RANK #68/326
This study reports results from NRG-GY012, a phase 2 trial evaluating olaparib, cediranib, and their combination in 120 patients with recurrent, persistent, or metastatic endometrial cancer. Ninety-six baseline plasma samples were analyzed for circulating protein biomarkers to assess predictive and prognostic associations with progression-free survival and overall survival. The primary analysis focused on IL-6, which did not validate at the prespecified 2.9 pg/mL cut point but was associated with overall survival at a median cut point of 4.2 pg/mL, with higher IL-6 levels linked to longer OS benefit in cediranib arms. Secondary analyses identified osteopontin and placental growth factor as potential predictive biomarkers, and multiple prognostic markers were also identified, warranting further evaluation.
10.1002/cncr.70649
Camrelizumab plus chemotherapy as induction therapy followed by concurrent chemoradiotherapy and camrelizumab consolidation in limited-stage small cell lung cancer: a randomized phase II trial.
SIGNAL TRANSDUCT TAR · Q1 JOURNAL - RANK #1/319TOP-TIER
This randomized phase II trial evaluated induction camrelizumab plus etoposide-platinum chemotherapy followed by concurrent chemoradiotherapy and camrelizumab consolidation versus induction chemotherapy plus concurrent chemoradiotherapy alone in 41 previously untreated limited-stage small cell lung cancer patients. The primary endpoint was 1-year progression-free survival rate; secondary endpoints included objective response rate, PFS, overall survival, and safety. At median follow-up of 32.1 months, the camrelizumab group demonstrated significantly higher 1-year PFS (65.5% vs 47.4%, P=0.029), longer median PFS (24.0 vs 11.8 months), and improved median OS (not reached vs 23.9 months, P=0.042), with manageable toxicities including 4.8% severe immune-related adverse events. The authors conclude that this induction-consolidation camrelizumab strategy significantly improved survival outcomes with a manageable safety profile, warranting further validation.
10.1038/s41392-026-02984-y
Feasibility of a tubeless enhanced recovery strategy in non-high-risk patients undergoing laparoscopy-assisted gastrectomy for gastric cancer.
SURG ENDOSC · Q1 JOURNAL - RANK #64/312
This prospective non-randomized controlled trial evaluated the feasibility of a tubeless enhanced recovery after surgery (ERAS) protocol in 205 non-high-risk gastric cancer patients undergoing laparoscopy-assisted gastrectomy. Patients were allocated 1:1 to ERAS-tubeless or ERAS-tube groups using a team-level allocation protocol, with postoperative hospital stay as the primary outcome. The tubeless group had significantly shorter mean hospital stays (6.0 vs. 7.3 days; P<0.001) and higher quality-of-life scores on multiple domains, without increased early complications. The authors conclude that the ERAS-tubeless strategy facilitates recovery and enhances patient experience, warranting further validation.
10.1007/s00464-026-13467-0
Clinical Efficacy of Tislelizumab Plus Gemcitabine-Nab-Paclitaxel for Borderline Resectable Pancreatic Cancer and Chemoresistance Analysis: A Prospective Pilot Study.
ANN SURG ONCOL · Q1 JOURNAL - RANK #39/312
This prospective pilot study evaluated the clinical feasibility of neoadjuvant tislelizumab plus gemcitabine-nab-paclitaxel in 30 patients with borderline resectable pancreatic cancer, with primary endpoints of R0 resection rate and treatment-related adverse events. Results showed 80.0% (24/30) completed neoadjuvant therapy and underwent resection, with R0 resection achieved in 80.0% (24/30) of all patients and 100% (24/24) of resected patients; 12-month OS and RFS rates were 87.5% and 82.8%, respectively, with median RFS of 28 months. Most TRAEs were grade I-II with no serious events, and exploratory proteomics/machine learning identified NT5DC2, FAM3D, CXCL5, and TMT1B as candidate resistance biomarkers. The authors conclude that this neoadjuvant regimen is promising for improving resection rates in BRPC with a favorable safety profile, warranting validation in larger-scale studies.
10.1245/s10434-026-20711-3
Randomized Trial of Hypofractionated Postmastectomy Radiation Therapy in Women With Breast Reconstruction (RT CHARM, Alliance A221505).
J CLIN ONCOL · Q1 JOURNAL - RANK #6/326TOP-TIER
This noninferiority randomized trial compared hypofractionated (42.56 Gy in 16 fractions) versus conventional (50 Gy in 25 fractions) postmastectomy radiation therapy in 898 women with breast cancer undergoing immediate or delayed breast reconstruction, with a median follow-up of 3.9 years and 825 evaluable for the primary endpoint. The primary outcome was a composite 24-month reconstruction complication rate, which was 12.3% (52/422) with hypofractionation versus 10.2% (41/403) with conventional therapy, yielding a difference of -2.1% (95% CI, -6.5 to 2.2), within the prespecified 10% noninferiority margin. Complication rates were higher with implant-only versus autologous reconstruction (odds ratio = 1.65), and 36-month locoregional recurrence rates were low and not significantly different (1.5% vs 2.2%). The authors conclude that a 16-fraction hypofractionated PMRT course is safe and noninferior to conventional PMRT in women undergoing breast reconstruction after mastectomy.
10.1200/JCO-26-00474
Oct 05 – Oct 12, 2026
First-line toripalimab in combination with platinum-doublet chemotherapy for advanced B3 thymoma and thymic carcinoma: an open-label prospective phase Ⅱ trial.
ESMO OPEN · Q1 JOURNAL - RANK #36/326
This open-label prospective phase II trial evaluated first-line toripalimab plus paclitaxel and carboplatin in 24 patients with advanced B3 thymoma and thymic carcinoma. Participants received combination therapy every 3 weeks for up to six cycles, followed by toripalimab maintenance until progression or discontinuation. Median progression-free survival was 19.3 months, with an objective response rate of 37.5% and disease control rate of 100%; grade 3-4 treatment-related adverse events occurred in 50% of patients. The authors conclude that this combination is an emerging therapeutic option with acceptable toxicity, and that tumor microenvironment features may serve as prognostic indicators.
10.1016/j.esmoop.2026.108366
Phase I/II Study of Bavdegalutamide, a Proteolysis-Targeting Chimera Androgen Receptor Degrader, in Metastatic Castration-Resistant Prostate Cancer.
J CLIN ONCOL · Q1 JOURNAL - RANK #6/326TOP-TIER
This phase I/II trial evaluated bavdegalutamide, a PROTAC androgen receptor degrader, in 239 patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with an AR pathway inhibitor. In phase I (N=95), the recommended phase II dose was 420 mg once daily; phase II administered this dose in 28-day cycles across AR molecular profile-defined subgroups. PSA50/PSA30 response rates reached 60.0%/70.0% in tumors with AR T878/H875 mutations (n=20), versus 4.3%/6.5% in wild-type/other AR alterations (n=46) and 3.1%/6.3% in AR L702H/splice variant 7 (n=32), with median rPFS of 11.1, 4.2, and 5.1 months, respectively. The authors conclude bavdegalutamide has a manageable safety profile and promising clinical activity, particularly in AR T878/H875-mutated mCRPC.
10.1200/JCO-25-02995
First-in-human phase Ia study of the covalent TEAD palmitoylation inhibitor BPI-460372 in patients with advanced solid tumors: pharmacokinetics, exposure-limited dosing, and early antitumor activity.
BIOMARK RES · Q1 JOURNAL - RANK #12/195TOP-TIER
This first-in-human, open-label, multicenter, single-arm phase Ia dose-escalation study evaluated the covalent TEAD palmitoylation inhibitor BPI-460,372 in 28 patients with advanced solid tumors who had progressed on or lacked standard therapies. Using a modified 3+3 design with accelerated titration, oral BPI-460,372 was escalated from 10 mg to 240 mg daily, with additional twice-daily and postprandial cohorts; primary endpoints were safety, tolerability, DLTs, and MTD, while secondary endpoints included pharmacokinetics and preliminary antitumor efficacy by RECIST 1.1. No DLTs occurred and the MTD was not reached, but all patients had at least one TEAE, 89.3% had treatment-related AEs with 39.3% grade ≥3, and one treatment-related death occurred; PK showed rapid absorption, dose-dependent exposure, steady state, and limited accumulation. One confirmed partial response yielded an ORR of 3.6% and DCR of 64.3%, with median PFS of 5.6 months and median OS of 13.2 months, supporting further evaluation with optimized dosing in Hippo pathway-dependent tumors despite exposure-limited dosing.
10.1186/s40364-026-01012-z
A randomised, open-label, phase II study of tobemstomig combinations in patients with previously untreated advanced clear-cell renal cell carcinoma.
ESMO OPEN · Q1 JOURNAL - RANK #36/326
This randomised, open-label, phase II trial evaluated tobemstomig plus axitinib and tobemstomig plus tiragolumab plus axitinib versus pembrolizumab plus axitinib in 198 patients with previously untreated advanced clear-cell renal cell carcinoma. Following a protocol-specified interim futility analysis, the study was terminated and the primary endpoint was amended from progression-free survival and adverse events to adverse events alone, with efficacy assessed descriptively. Grade 3-4 adverse events occurred in 62.1%, 67.7%, and 56.7% of patients, and treatment-related serious adverse events in 22.7%, 29.2%, and 13.4%, across the tobemstomig-axitinib, tobemstomig-tiragolumab-axitinib, and control arms, respectively. Confirmed overall response rates were 51.5%, 53.8%, and 51.5%, with median progression-free survival of 12.4, 12.5, and 12.5 months. The authors concluded that tobemstomig-containing regimens increased toxicity without meaningful efficacy improvement versus control.
10.1016/j.esmoop.2026.108587
Efficacy and Safety of Alectinib in Pediatric and Adult Patients with ALK-Altered Advanced Solid Tumors: a phase II TACKLE Trial (NCCH1712/MK003).
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This open-label, multicenter phase II TACKLE trial evaluated alectinib in 26 pediatric and adult patients with advanced ALK-altered solid tumors across 11 tumor types. The primary endpoint was centrally confirmed objective response rate (ORR) per RECIST v1.1, assessed using a Bayesian design in patients receiving intact capsules (Cohort A). In Cohort A (n=16), ORR was 43.8%, meeting the primary endpoint; among all evaluable patients (n=24), ORR was 54.2% and DCR 75.0%, with median PFS of 24.9 months and OS of 38.8 months. Alectinib demonstrated meaningful, durable responses with acceptable safety (grade ≥3 TRAEs: 15.4%), supporting further tumor-agnostic development.
10.1158/1078-0432.CCR-26-1548
Clinical impact of early enteral nutrition support on gastrointestinal function, nutritional status, liver function, and immune function in liver cancer patients.
FRONT MED-LAUSANNE · Q1 JOURNAL - RANK #61/332
This randomized controlled trial evaluated early enteral nutrition (EEN) versus total parenteral nutrition (TPN) in 80 primary liver cancer patients treated between December 2022 and December 2023, with 40 patients per group receiving isocaloric and isonitrogenous nutritional support after surgery. The primary outcome was change in serum albumin from baseline to postoperative day 7, with secondary outcomes including gastrointestinal recovery, nutritional markers (DAO, PA), liver function markers (ChE, AST, ALT), immune markers (CD4+, CD8+, CD4+/CD8+ ratio), adverse reactions, and exploratory clinical outcomes. The EEN group showed significantly higher postoperative ALB levels (30.5±2.5 vs. 26.2±2.7 g/L; mean difference 4.3 g/L, 95% CI: 2.8-5.8, p<0.001), faster gastrointestinal recovery (all p<0.001), and significant group×time interactions for all nutritional, liver, and immune markers (all p<0.001). EEN also had shorter hospital stay (12.5±3.2 vs. 16.8±4.1 days, p<0.001) and fewer adverse reactions (2.5% vs. 20.0%, p=0.013), with no significant differences in infection, readmission, or liver failure rates.
10.3389/fmed.2026.1769787
FIND: a phase-II study to evaluate the efficacy and safety of erdafitinib in FGFR-altered NSCLC.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This phase-II trial evaluated erdafitinib, a selective FGFR1-4 inhibitor, in patients with FGFR-altered non-small cell lung cancer (NSCLC). Patients were screened within the national Network Genomic Medicine and assigned to three cohorts: high-confidence FGFR fusions, high-confidence FGFR mutations, and low-confidence FGFR alterations, with the primary endpoint of best confirmed overall response rate (ORR) in cohorts 1 and 2 using Simon’s two-stage design. Among 44,537 screened patients, 26 were enrolled and 22 treated (7 in cohort 1, 8 in cohort 2, 7 in cohort 3). In cohort 1, two of seven patients achieved partial response (one unconfirmed), while cohort 2 showed only stable disease as best response; common adverse events included hyperphosphatemia (45.5%), diarrhea (31.8%), and dry mouth (31.8%). The authors conclude that erdafitinib showed preliminary efficacy in FGFR-fusion-positive NSCLC, but further data are needed, especially for FGFR mutations.
10.1158/1078-0432.CCR-26-1485
Summary of Research: Two-Stage Estimation of Overall Survival in the Phase 3 CheckMate 9ER Trial, Adjusting for the Impact of Subsequent Therapy.
ADV THER · Q1 JOURNAL - RANK #82/352
This study conducted a post hoc analysis of the phase 3 CheckMate 9ER trial using two-stage estimation to assess overall survival benefits of cabozantinib plus nivolumab (CaboNivo) versus sunitinib (SUN) in advanced renal cell carcinoma, adjusting for subsequent therapy effects. The two-stage approach first modeled how subsequent therapy extended survival in patients discontinuing original treatment, then calculated adjusted hazard ratios. Results showed TSE-adjusted median OS of 42.7 months for CaboNivo versus 21.3 months for SUN (HR 0.53, 95% CI 0.43-0.65, p<0.001), compared to unadjusted estimates of 46.5 versus 35.5 months (HR 0.79, p=0.0196). The analysis demonstrated that removing subsequent therapy effects increased the estimated OS benefit, reinforcing CaboNivo as first-line standard of care for advanced renal cell carcinoma.
10.1007/s12325-026-03773-3
Sofetabart mipitecan, an antibody drug conjugate targeting folate receptor alpha, in high grade ovarian cancer: Results from the first-in-human phase 1 study.
ANN ONCOL · Q1 JOURNAL - RANK #4/326TOP-TIER
This first-in-human, multicenter, open-label phase 1 trial evaluated the novel FRα-targeting antibody-drug conjugate sofetabart mipitecan in 105 heavily pretreated patients with high-grade ovarian cancer, regardless of FRα expression level, at doses of 2, 3, 4, or 6 mg/kg every 21 days. The overall response rate was 50.5% (95% CI 40.5–60.4), with median progression-free survival of 8.1 months, and activity was observed across subgroups including FRα <75% (44.4%) and prior MIRV exposure (57.9%). The most common treatment-emergent adverse events were nausea (64.8%), fatigue (56.2%), and anemia (47.6%), with no keratopathies or grade ≥3 neuropathy and grade ≥3 treatment-related TEAE rates of 35.3% at 3 mg/kg and 56.4% at 4 mg/kg. The authors conclude that sofetabart mipitecan has a favorable tolerability profile with durable clinical activity, supporting 3 mg/kg as the recommended phase 3 dose.
10.1016/j.annonc.2026.10.001
Exploration of tumor genomics associated with prolonged benefit from or resistance to talazoparib monotherapy in patients with metastatic castration-resistant prostate cancer.
EUR J CANCER · Q1 JOURNAL - RANK #45/326
This study explored tumor genomics associated with prolonged benefit or resistance to talazoparib monotherapy in patients with metastatic castration-resistant prostate cancer (mCRPC) using data from the phase II TALAPRO-1 trial. Tumor genetics were retrospectively assessed in 104 patients from the efficacy population, categorized by radiographic progression-free survival (rPFS: ≥12 months, ≥2 to <12 months, <2 months), and serial circulating tumor DNA samples were analyzed for emergent mutational changes using FoundationOne Liquid CDx. Among 16 patients with rPFS ≥12 months, 15 (94%) had tumor BRCA2 alterations versus 6/27 (22%) with rPFS <2 months (p<0.00001); HRR gene reversions were detected in 7/27 patients and emergent PARP1 variants in 5/27 evaluable patients. The authors conclude that prolonged benefit is associated with BRCA2 alterations, while reversion mutations and PARP1 variants likely reflect selective pressure to escape talazoparib synthetic lethality or PARP trapping.
10.1016/j.ejca.2026.117079
RINGSIDE Phase II Study of Varegacestat for Treatment of Desmoid Tumors: A Randomized Dose-Finding Clinical Trial.
J CLIN ONCOL · Q1 JOURNAL - RANK #6/326TOP-TIER
The RINGSIDE phase II study evaluated varegacestat, an oral gamma-secretase inhibitor, in adults with desmoid tumors. This open-label, randomized, dose-finding trial assigned 42 participants 1:1:1 to 1.2-mg once-daily, 2-mg intermittent, or 4-mg intermittent dosing, with safety as the primary end point and tumor volume change at week 16 as the secondary end point. Median tumor volume reduction at week 16 was -51.91%, -15.25%, and -9.50%, respectively, with confirmed ORRs of 35.7%, 21.4%, and 21.4%; in the open-label extension, median best tumor volume change was -85.88% and ORR rose to 57.1%. Varegacestat produced clinically meaningful tumor reduction with a manageable safety profile, and the 1.2-mg once-daily dose was selected for phase III.
10.1200/JCO-26-00725
Disitamab Vedotin Plus Tislelizumab in Transurethrally Unresectable, ERBB2-Positive, Non-Muscle-Invasive Bladder Cancer: A Nonrandomized Clinical Trial.
JAMA ONCOL · Q1 JOURNAL - RANK #14/326TOP-TIER
This open-label, single-arm, phase 2 nonrandomized clinical trial evaluated disitamab vedotin plus tislelizumab in 28 adults with transurethrally unresectable ERBB2-positive very high-risk non-muscle-invasive bladder cancer who were ineligible for or declined cystectomy. Patients received intravenous disitamab vedotin (120 mg) plus tislelizumab (200 mg) every 3 weeks for 3 cycles, with responders receiving up to 8 and 17 cycles respectively. Complete response of high-risk disease occurred in 19 of 26 efficacy-evaluable patients (73.1%; 95% CI, 54.8%-91.3%), meeting the prespecified 70% alternative-rate goal, with 24-month sustained response of 83.5% among responders and no muscle-invasive or metastatic progression. The authors conclude that this combination may yield high complete response rates and durable disease control, supporting future randomized trials.
10.1001/jamaoncol.2026.3909
Allogeneic stem cell transplantation in aggressive Adult T cell leukemia/lymphoma: a prospective multicenter study.
BLOOD ADV · Q1 JOURNAL - RANK #13/98
This prospective multicenter trial evaluated the feasibility and outcomes of allogeneic stem cell transplantation (allo-SCT) following frontline chemotherapy in 80 aggressive Adult T-cell leukemia/lymphoma (ATL) patients, with 39 ultimately proceeding to allo-SCT using a Thiotepa-Busulfan-Fludarabine conditioning regimen. Two-year overall survival from first-line therapy was 45%, and time-dependent analysis demonstrated a significant survival benefit for allo-SCT (hazard ratio, 0.32). Three-year overall survival and progression-free survival were both 52%, with one-year non-relapse mortality of 15% and cumulative relapse incidence of 35%; absence of complete or partial response at allo-SCT was the primary risk factor for poor outcomes. The authors conclude that allo-SCT provides benefit in eligible ATL patients, supported by molecular evidence of undetectable tumor clones post-transplant suggesting a potent graft-versus-ATL effect.
10.1182/bloodadvances.2026020323
Targeting CD6 in solid tumors: safety, early efficacy, and mechanistic insights from a proof-of-concept trial of itolizumab.
J IMMUNOTHER CANCER · Q1 JOURNAL - RANK #12/183TOP-TIER
This first-in-human, two-arm, open-label proof-of-concept trial evaluated the anti-CD6 monoclonal antibody itolizumab in patients with advanced, heterogeneous solid tumors. Treatment comprised an induction phase (group A: 100 mg weekly for nine doses; group B: 200 mg biweekly for five doses) followed by maintenance (100 mg every 21 days for up to six doses), with safety as the primary endpoint and disease control, survival, and exploratory biomarkers as secondary objectives. No safety-related discontinuations, related serious adverse events, or unexpected toxicities occurred; disease control was achieved in 25% (group A) and 20% (group B), with 1-year survival rates of 26% and 15%, respectively. Mechanistically, itolizumab downregulated CD6, increased soluble CD6, promoted cytotoxic CD8/NK phenotypes, and enhanced in vitro killing of CD318+ cancer cells. The authors conclude that itolizumab has a favorable safety profile and supports further development as an immunomodulatory strategy for advanced solid tumors, particularly CD318-expressing tumors and combination regimens.
10.1136/jitc-2026-016182
PARAGON-II cohort C: a phase II basket study of letrozole plus ribociclib in hormone receptor-positive, platinum-resistant, high-grade epithelial ovarian cancer.
INT J GYNECOL CANCER · Q1 JOURNAL - RANK #8/140
PARAGON-II Cohort C is a multicenter phase II basket trial evaluating letrozole plus ribociclib in 32 patients with hormone receptor-positive, PIK3CA wild-type, platinum-resistant high-grade epithelial ovarian cancer. Participants received letrozole 2.5 mg daily and ribociclib 600 mg (3 weeks on/1 week off) until progression or toxicity, with the primary endpoint of objective response rate by RECIST v1.1 or GCIG CA125 criteria. Among 25 patients with measurable disease, the objective response rate was 4.0% (1 partial response), with a 12-week disease control rate of 27.0% and median progression-free survival of 1.9 months. The authors conclude that letrozole plus ribociclib demonstrated minimal clinical activity, not supporting further evaluation of this specific combination in this population.
10.1016/j.ijgc.2026.105600
Neoadjuvant niraparib monotherapy for unresectable, homologous recombination deficiency-positive, high-grade serous ovarian cancer (NANT): a multicentre, single-arm, phase 2 trial.
LANCET ONCOL · Q1 JOURNAL - RANK #8/326TOP-TIER
This multicentre, single-arm, phase 2 trial evaluated neoadjuvant niraparib monotherapy in 67 patients with treatment-naïve, HRD-positive, advanced high-grade serous or endometrioid ovarian cancer initially unsuitable for primary debulking surgery. Patients received oral niraparib for two 28-day cycles, with co-primary endpoints of objective response rate and R0 resection rate after interval debulking surgery. Among 48 response-evaluable patients, the objective response rate was 63% (95% CI 47-76), and among 40 operated patients, the R0 resection rate was 80% (95% CI 64-91). The authors conclude that neoadjuvant niraparib showed anti-tumour activity and enabled R0 resection, but requires randomised validation against standard neoadjuvant chemotherapy.
10.1016/S1470-2045(26)00387-6
Tislelizumab plus lenvatinib in advanced fumarate hydratase-deficient renal cell carcinoma: a single-arm, phase 2 trial with metabolic biomarker analysis.
NAT COMMUN · Q1 JOURNAL - RANK #10/135TOP-TIER
This single-arm, phase 2 trial evaluated first-line tislelizumab plus lenvatinib in 20 patients with advanced fumarate hydratase-deficient renal cell carcinoma, with objective response rate as the primary endpoint. At a median follow-up of 20.2 months, the ORR was 95% (95% CI 75.1-99.9), DCR was 100%, median PFS was 20.7 months, median DOR was 19.2 months, and 2-year OS was 89.7%, with grade ≥3 treatment-related adverse events in 45%. Circulating succinyl-adenosine and succinic-cysteine tracked tumor burden in 80% of patients. The authors conclude that tislelizumab plus lenvatinib shows promising antitumor activity and manageable safety as a potential first-line option for advanced FH-RCC, though limitations include the single-center, single-arm design and small sample size.
10.1038/s41467-026-77615-9
Canakinumab with chemoradiation and durvalumab consolidation in unresectable stage III non-small cell lung cancer: the phase I/II CHORUS trial.
NAT COMMUN · Q1 JOURNAL - RANK #10/135TOP-TIER
The CHORUS trial (NCT04905316) was an open-label, non-randomized, single-arm phase I/II study evaluating canakinumab, an anti-IL-1beta monoclonal antibody, combined with concurrent chemoradiotherapy followed by durvalumab consolidation in 41 patients with unresectable stage III non-small cell lung cancer. The primary endpoint of 24-month progression-free survival was met at 67% (95% CI, 52-88), exceeding the prespecified historical benchmark of 46%, with 12- and 24-month overall survival rates of 93% and 73%, respectively, and a confirmed objective response rate of 81%. Grade 3-4 canakinumab-related adverse events included neutropenia (n=5), febrile neutropenia (n=1), lymphopenia (n=1), lung infection (n=1), fatigue (n=1), and hypertension (n=1), with no treatment-related deaths; pneumonitis occurred in 24% of patients. The authors conclude these findings support randomized evaluation of interleukin-1beta blockade in this clinical setting.
10.1038/s41467-026-77415-1
MK-4002, a B-cell maturation antigen-targeting T-cell engager, in relapsed or refractory multiple myeloma: a first-in-human, open-label, phase 1 study.
LANCET HAEMATOL · Q1 JOURNAL - RANK #3/98TOP-TIER
This first-in-human, open-label, phase 1 trial evaluated the trispecific BCMA-targeting T-cell engager MK-4002 in 97 patients with relapsed or refractory multiple myeloma across 12 sites. Using a dose-escalation design (0.005–24 mg weekly or every 2 weeks), the study assessed safety, pharmacokinetics, and overall response rate (ORR) as primary and key secondary endpoints. Dose-limiting toxicities occurred in six patients, cytokine release syndrome in 30%, and ORR was 41% (2.15–6 mg), 63% (12 mg), and 48% (24 mg); the 12 mg dose was identified as the preliminary recommended phase 2 dose. MK-4002 demonstrated manageable safety and clinical activity in heavily pretreated patients, supporting further evaluation at 12 mg.
10.1016/S2352-3026(26)00228-0
Neoadjuvant PD1 plus CTLA-4 immune checkpoint blockade in surgically resectable recurrent glioblastoma: a randomized surgical window-of-opportunity trial.
NAT COMMUN · Q1 JOURNAL - RANK #10/135TOP-TIER
This randomized surgical window-of-opportunity trial evaluated neoadjuvant PD1 plus CTLA-4 immune checkpoint blockade in 63 randomized patients with surgically resectable recurrent glioblastoma, comparing dual ICB (nivolumab plus ipilimumab), nivolumab alone, or placebo before surgery, with 58 receiving study treatment. The primary endpoint of tumor-infiltrating lymphocyte density was met for dual ICB versus untreated control, and median overall survival was 402 days for dual ICB arms versus 273 days for nivolumab alone. No unanticipated toxicities occurred, and exploratory analyses linked higher TIL density and early systemic interferon signatures with improved survival. The authors conclude that dual ICB demonstrates pharmacodynamic activity in glioblastoma with favorable survival outcomes.
10.1038/s41467-026-77433-z
Efficacy of Cryotherapy in Preventing Taxane-Induced Neuropathy: The CryoPac Randomised Controlled Trial.
ANN ONCOL · Q1 JOURNAL - RANK #4/326TOP-TIER
This randomized controlled trial evaluated cryotherapy using frozen gloves and socks versus usual care to prevent taxane-induced peripheral neuropathy in 268 cancer patients. Participants were stratified by site and regimen, randomized 1:1, with 217 analyzed (123 cryotherapy, 94 control) after 51 dropouts. The primary endpoint, CIPN incidence (TNS ≥2) at end of treatment, was 74% with cryotherapy versus 84% with control (P=.071), not statistically significant, though cryotherapy reduced patient-reported tingling, numbness, and tactile disturbance on secondary measures. The authors concluded that cryotherapy did not significantly reduce CIPN incidence but may offer symptomatic benefits.
10.1016/j.annonc.2026.09.014
First-line durvalumab and tremelimumab in poor-prognosis unresectable hepatocellular carcinoma: Phase IIIb single-arm SIERRA study.
J HEPATOL · Q1 JOURNAL - RANK #3/147TOP-TIER
The phase IIIb single-arm SIERRA study evaluated first-line STRIDE (tremelimumab plus durvalumab) in 111 adults with unresectable hepatocellular carcinoma and poor prognostic factors, including Child-Pugh B7/B8 (n=44), ECOG PS 2 (n=47), or Vp4 portal vein thrombosis (n=20). Participants received tremelimumab 300 mg plus durvalumab 1500 mg once, then durvalumab 1500 mg every 4 weeks until progression, unacceptable toxicity, or withdrawal. The incidence of Grade 3/4 treatment-related adverse events within 6 months was 19.8% (95% CI 12.9-28.5), and the objective response rate was 14.4% (95% CI 8.5-22.4), with cohort-specific ORRs of 6.8%, 21.3%, and 15.0%, respectively. The authors concluded that STRIDE showed a favourable risk-benefit profile in this underrepresented poor-prognosis population.
10.1016/j.jhep.2026.10.002
Impact of Primary Prophylactic Colony-Stimulating Factor Delivery Method on Febrile Neutropenia: Secondary Analysis of a Pragmatic Cluster Randomized Clinical Trial.
JCO ONCOL PRACT · Q1 JOURNAL - RANK #81/326
This secondary analysis of the SWOG S1415CD pragmatic cluster-randomized trial evaluated whether primary prophylactic colony-stimulating factor delivery method affects febrile neutropenia incidence in 1,713 women receiving first-line breast cancer chemotherapy. Patients received PP-CSF via in-clinic administration (45%), on-body device (50%), or home self-injection (5%), with FN occurring in 3.8%, 5.0%, and 6.4% respectively. FN was significantly associated with high-risk regimens (OR 2.97) and poor performance status (OR 4.99) but not delivery method or agent. The authors conclude that FN rates are low regardless of delivery method and that delivery decisions may be guided by patient-centered factors.
10.1200/OP-26-00296
Effect of a Computer-Aided Device on Endoscopists’ Biopsy Practice for Gastric Neoplasms: A Secondary Analysis of a Randomized Controlled Trial.
DIGEST ENDOSC · Q1 JOURNAL - RANK #17/312
This secondary analysis of a randomized controlled trial evaluated whether AI-assisted endoscopy improves endoscopists’ biopsy strategies for gastric neoplasms. The trial compared AI-assisted screening (n=13,440) versus standard screening (n=12,561), with the AI group stratified into red-box and non-red-box subgroups based on AI alerts. The red-box group showed significantly lower non-biopsy rates (18.00% vs 43.26% and 45.60%, p<0.001) and higher neoplasm biopsy efficiency (8.19% vs 0.36% and 1.77%, p<0.001), with red-box classification independently associated with lower non-biopsy rates (IRR 0.393, 95% CI 0.360-0.429). The authors conclude that red-box classification promotes more targeted biopsy sampling without causing indiscriminate biopsies from false-positive alerts.
10.1111/den.70302
Cadonilimab plus lenvatinib in advanced endometrial cancer: the multicenter single-arm phase II CLEAR-EC trial.
NAT COMMUN · Q1 JOURNAL - RANK #10/135TOP-TIER
The CLEAR-EC multicenter single-arm phase II trial evaluated cadonilimab plus lenvatinib as second-line or later therapy in advanced endometrial cancer after platinum-based chemotherapy. Thirty-two patients were enrolled, including three in a safety run-in, with the primary endpoint of objective response rate. The trial met its primary endpoint with an objective response rate of 40.6% (95% CI 23.7-59.4), disease control rate of 81.3% (95% CI 63.6-92.8), median progression-free survival of 13.8 months, and median overall survival not reached; grade ≥3 treatment-related adverse events occurred in 40.6%. The authors conclude that cadonilimab plus lenvatinib is active and has a manageable safety profile in this population.
10.1038/s41467-026-77467-3
A randomized trial to evaluate the effect of epigallocatechin gallate (EGCG) on EBV reactivation in patients with nasopharyngeal carcinoma in remission -the TCOG T2312 study.
EUR J CANCER · Q1 JOURNAL - RANK #45/326
This randomized controlled trial evaluated epigallocatechin gallate (EGCG) versus placebo for preventing Epstein-Barr virus reactivation in 327 evaluable nasopharyngeal carcinoma patients in remission after radiation-based treatment. Patients were randomized to receive EGCG or placebo for 3 years with periodic monitoring of EBV-related antibodies and EBV DNA. No significant difference was observed in EBV DNA reactivation or recurrence rates between groups, and EGCG toxicity was minimal. The study concluded that EGCG did not reduce EBV reactivation or tumor recurrence, but confirmed EBV DNA as a prognostic marker for recurrence, recurrence-free survival, and overall survival.
10.1016/j.ejca.2026.117445
Type II ROS1 Inhibition Overcomes Type I Inhibitor Resistance in ROS1 Fusion-Positive Lung Cancers: A Phase II Trial of Cabozantinib.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This single-center, open-label, phase 2 trial evaluated cabozantinib, a type II ROS1/MET tyrosine kinase inhibitor, in 7 patients with pre-treated ROS1 fusion-positive NSCLC enrolled in the first stage of a Simon two-stage design. The primary endpoint was overall response rate, with secondary endpoints of progression-free survival, overall survival, and safety. The ORR was 43% (95% CI, 10-81.5%), including partial responses in patients with ROS1 D2033N and G2032R/L2086F mutations, with median PFS of 4.5 months (95% CI, 4-NE), median duration of response of 8.0 months (range 3-13), and median OS of 11 months (95% CI, 6-NE). Grade 3 treatment-related adverse events occurred in 57%, all patients required dose reduction, and resistance mechanisms included MET overexpression and MET D1228N, supporting type II ROS1 inhibition as a strategy to overcome type I inhibitor resistance.
10.1158/1078-0432.CCR-26-2860
Efficacy and Safety of Olaparib plus Abiraterone Versus Placebo plus Abiraterone in the Non-BRCA Mutation Subgroup of Patients with Metastatic Castration-resistant Prostate Cancer in the PROpel Trial.
EUR UROL ONCOL · Q1 JOURNAL - RANK #7/133
This post hoc exploratory analysis of the phase 3 PROpel trial evaluated olaparib plus abiraterone versus placebo plus abiraterone in 693 patients with non-BRCA-mutated metastatic castration-resistant prostate cancer. Patients were randomized 1:1 to receive olaparib or placebo plus abiraterone with prednisone/prednisolone. Median investigator-assessed radiographic progression-free survival was 24.1 months for olaparib plus abiraterone versus 19.0 months for placebo plus abiraterone (HR 0.76, 95% CI 0.61-0.94), while median overall survival was 39.6 versus 38.0 months (HR 0.91, 95% CI 0.73-1.13). The authors concluded that olaparib plus abiraterone provided numerically longer rPFS with no new safety signals, supporting it as a treatment option for non-BRCA-mutated mCRPC.
10.1016/j.euo.2026.08.014
Effect of erlotinib and celecoxib as short-course neoadjuvant therapy in operable oral cavity squamous cell carcinoma: a randomized controlled window-of-opportunity trial.
ORAL ONCOL · Q1 JOURNAL - RANK #18/162
This randomized phase II window-of-opportunity trial evaluated short-course neoadjuvant erlotinib and celecoxib during the preoperative waiting period in 63 patients with resectable oral cavity squamous cell carcinoma. Patients were randomized to celecoxib, erlotinib, combination therapy, or observation for 21 days before surgery, with biomarker modulation as the primary endpoint and tumor response, safety, and feasibility as secondary endpoints. Erlotinib exposure significantly reduced CD31 (p<0.001), CD34 (p=0.006), and cytoplasmic AKT (p=0.006), while celecoxib reduced CD31 (p=0.003); partial clinical responses occurred in 43.7% with erlotinib and 60% with combination therapy, and erlotinib-containing regimens reduced or stabilized tumor size versus progression in the observation arm. The authors conclude that short-course neoadjuvant erlotinib, particularly with celecoxib, is feasible, safe, and biologically active in operable OCSCC, supporting further evaluation to prevent progression during surgical delays.
10.1016/j.oraloncology.2026.108156
First-line tislelizumab plus chemotherapy versus placebo plus chemotherapy in unresectable advanced/metastatic esophageal squamous cell carcinoma: minimum 3-year survival follow-up of a randomized phase 3 trial (RATIONALE-306).
NAT COMMUN · Q1 JOURNAL - RANK #10/135TOP-TIER
This randomized phase 3 trial evaluated first-line tislelizumab plus chemotherapy versus placebo plus chemotherapy in 649 patients with unresectable advanced/metastatic esophageal squamous cell carcinoma. At a minimum 3-year follow-up, tislelizumab plus chemotherapy significantly improved overall survival (17.2 vs 10.6 months; HR 0.70; 95% CI 0.59-0.80), with 15.0% versus 2.9% progression-free at 3 years. Safety was tolerable with no new signals, and quality of life favored tislelizumab, with median time to deterioration of physical functioning not reached versus 18.8 months. The authors conclude tislelizumab plus chemotherapy offers long-lasting efficacy and favorable patient-reported outcomes, supporting it as a suitable first-line option.
10.1038/s41467-026-77327-0
Integrative Multiomics Profiling Reveals Immune Determinants of Response to Disitamab Vedotin Plus Penpulimab in HER2-Low Breast Cancer.
MEDCOMM · Q1 JOURNAL - RANK #14/195TOP-TIER
This prospective single-arm phase II trial evaluated neoadjuvant disitamab vedotin plus penpulimab in 20 patients with Stage II-III HER2-low breast cancer, administering six cycles every three weeks before surgery. In the intention-to-treat population, the pathologic complete response rate was 20.0% (4/20; 95% CI, 5.7-43.7%) and the objective response rate was 45.0% (9/20; 95% CI, 23.1-68.5%). Grade ≥3 adverse events occurred in 25.0% with no treatment-related deaths, and exploratory multiomics analyses identified immune-active microenvironment features associated with pCR. The authors conclude the combination shows preliminary antitumor activity with manageable safety, but the small sample size and wide confidence intervals preclude definitive conclusions and warrant validation in larger randomized trials.
10.1002/mco2.70988
Phase 1 dose escalation and expansion trial of the bispecific CD47 inhibitor and CD40 agonist Fc-fusion protein SL-172154 (SIRPα-Fc-CD40L) in patients with higher-risk myelodysplastic syndrome or acute myeloid leukemia.
CANCER-AM CANCER SOC · Q1 JOURNAL - RANK #68/326
This phase 1 dose escalation and expansion trial evaluated the bispecific CD47 inhibitor and CD40 agonist Fc-fusion protein SL-172154 alone or combined with azacitidine (AZA) in 81 patients with higher-risk myelodysplastic syndrome (HR-MDS, n=33) or acute myeloid leukemia (AML, n=48). Dose escalation tested 1, 3, and 6 mg/kg SL-172154; expansion used 3 mg/kg plus AZA in untreated HR-MDS (n=24, 21 TP53 mutant) and TP53 mutant AML (n=21). Complete remission occurred in 10/24 (43%) HR-MDS and 6/21 (29%) TP53m AML patients, with median overall survival of 11.0 and 11.7 months, respectively. The combination was generally well tolerated but showed no substantial survival improvement over historical benchmarks.
10.1002/cncr.70626
E7386 plus lenvatinib in patients with advanced endometrial cancer that progressed on platinum-based chemotherapy and an anti-PD-(L)1 immunotherapy: a single-arm, open-label, global phase 1b/2 dose-expansion cohort.
ECLINICALMEDICINE · Q1 JOURNAL - RANK #11/332
This global phase 1b/2 dose-expansion cohort evaluated E7386 plus lenvatinib in 30 patients with advanced endometrial cancer progressing after platinum-based chemotherapy and anti-PD-(L)1 immunotherapy. This single-arm, open-label trial administered E7386 120 mg twice daily plus lenvatinib 14 mg once daily (amended from 20 mg), with safety as the primary endpoint and ORR, duration of response, clinical benefit rate, and PFS as secondary endpoints. All patients experienced TEAEs (most commonly vomiting, 73.3%), with grade 3 TEAEs in 63.3% and no grade 4-5 events; confirmed responses occurred in 11 patients (one complete, ten partial) for an ORR of 36.7% overall and 57.1% in lenvatinib-naive patients. The authors conclude that E7386 plus lenvatinib shows promising antitumour activity with manageable safety in heavily pretreated advanced endometrial cancer.
10.1016/j.eclinm.2026.104206
Sep 28 – Oct 05, 2026
PSMA-PET/CT-guided Intensification of Radiation Therapy for Prostate Cancer (PSMAgRT): 5-yr Analysis of a Phase 2 Randomized Controlled Trial.
EUR UROL · Q1 JOURNAL - RANK #3/133TOP-TIER
This phase 2, two-center, open-label randomized controlled trial evaluated whether PSMA-PET/CT-guided radiotherapy (PSMAgRT) intensification improves failure-free survival (FFS) in prostate cancer patients planned for standard-of-care radiotherapy. A total of 262 patients were randomized 1:1 across four strata (salvage post-radical prostatectomy, high-risk, oligometastatic, and salvage post-RT), with 253 treated/analyzed and a median follow-up of 66 months. The primary FFS endpoint was not met (5-year FFS 66% vs 62%; HR 0.80; one-sided 90% CI upper bound 1.04; p=0.14), but freedom from biochemical progression favored PSMAgRT overall (72% vs 65%; sHR 0.70; p=0.048), with greater benefit in high-risk (81% vs 66%; sHR 0.54; p=0.07) and post-RP (80% vs 68%; sHR 0.54; p=0.037) strata. The authors conclude that although the primary endpoint was not met overall, treatment-effect estimates support PSMAgRT in high-risk and post-RP populations, providing rationale for the phase 3 PATRON trial. Only one grade ≥3 event was possibly related to dose escalation, and limitations include the phase 2 design and heterogeneous population.
10.1016/j.eururo.2026.09.017
Microwave ablation versus stereotactic body radiotherapy for oligometastatic colorectal liver metastases (LAVA-CRLM): a prospective, randomised, phase II trial.
LANCET REG HEALTH-EU · Q1 JOURNAL - RANK #3/185TOP-TIER
This prospective, randomised, phase II trial at two Danish centres compared microwave ablation (MWA) versus stereotactic body radiotherapy (SBRT) for oligometastatic colorectal liver metastases in adults with one to three lesions ≤4.0 cm. One hundred patients were randomised 1:1, with 92 in the modified intention-to-treat analysis; the primary endpoint was freedom from local progression and toxicity was assessed in the safety population. At median follow-up of 34.9 months, 1-year freedom from local progression was 77.7% with MWA versus 83.0% with SBRT (HR 0.87, 95% CI 0.43-1.74; p=0.70), while grade ≥2 treatment-related toxicity occurred in 25% of MWA patients versus 3% of SBRT patients, including one treatment-related death with MWA. The authors concluded that SBRT had a more favourable safety profile with no detected difference in local progression, supporting SBRT as a non-invasive option for selected patients.
10.1016/j.lanepe.2026.101879
Effect of dose-dense adjuvant chemotherapy in patients with node-positive early breast cancer according to estrogen receptor levels: an exploratory analysis of the GIM2 trial.
BREAST · Q1 JOURNAL - RANK #4/140
This exploratory analysis of the phase III GIM2 trial evaluated whether estrogen receptor (ER) expression levels predict benefit from dose-dense (DD) adjuvant chemotherapy in 1709 patients with node-positive early breast cancer randomized to DD versus standard-interval anthracycline-paclitaxel. ER expression was categorized as ER 0, ER-low (1-10%), ER-intermediate (11-50%), and ER-high (>50%), and associations with invasive disease-free survival (iDFS) and overall survival (OS) were assessed using multivariable Cox models and STEPP. At 15 years, iDFS rates were 48%, 59%, 56%, and 59% (p=0.001) and OS rates were 72%, 71%, 68%, and 75% (p<0.001) across ER categories, with no significant interaction between ER levels and treatment effect. The authors conclude that ER expression is prognostic but does not identify differential benefit from DD chemotherapy, supporting DD chemotherapy as an effective adjuvant option across the ER spectrum.
10.1016/j.breast.2026.104942
Tumor-Free Circulating Tumor DNA in Node-Negative Rectal Cancers Undergoing Neoadjuvant Chemotherapy, Excision, and Observation in the Phase II NEO Trial (CO.28).
JCO PRECIS ONCOL · Q1 JOURNAL - RANK #57/326
This prospective biomarker analysis within the phase II NEO trial (CO.28) evaluated circulating tumor DNA (ctDNA) using the Guardant Reveal epigenomic assay in 53 of 58 patients with cT1-3, node-negative rectal cancer treated with neoadjuvant chemotherapy followed by transanal excision. ctDNA was detected in 45.8% of patients pre-chemotherapy, decreased significantly to 8.7% post-chemotherapy and pre-TES (P < .0001). Post-chemotherapy ctDNA detection was associated with poor response and persistent cancer (P = .03), with 100% (4/4) of ctDNA-positive patients recommended for TME versus 38.1% (16/42) of ctDNA-negative patients. The authors conclude that ctDNA testing can identify inadequate responders and may support organ preservation decisions in early-stage rectal cancer.
10.1200/PO-26-00459
Linvoseltamab outcomes by frailty status in patients with relapsed/refractory multiple myeloma: a subgroup analysis of the LINKER-MM1 study.
BLOOD CANCER J · Q1 JOURNAL - RANK #24/326TOP-TIER
This post hoc subgroup analysis of the LINKER-MM1 prospective clinical trial evaluated linvoseltamab 200 mg in 117 patients with relapsed/refractory multiple myeloma, categorized by frailty using three measures. The study reported objective response rates and Grade 3/4 treatment-emergent adverse events across frail and non-frail groups over a median follow-up of 21.3 months. Response rates ranged from 62.5% to 74.2% in frail patients and 69.8% to 73.0% in non-frail patients, with consistent safety profiles. The authors conclude that linvoseltamab demonstrates a favorable risk-benefit profile in frail patients, warranting continued evaluation in clinical trials and real-world settings.
10.1038/s41408-026-01572-1
Toripalimab consolidation after chemoradiotherapy in limited-stage small cell lung cancer: a phase II, randomized controlled study (GASTO-1052A).
J IMMUNOTHER CANCER · Q1 JOURNAL - RANK #12/183TOP-TIER
This phase II randomized controlled trial evaluated toripalimab consolidation versus observation in 98 patients with limited-stage small cell lung cancer who had completed concurrent chemoradiotherapy. Patients were randomized 1:1 to toripalimab 240 mg every 3 weeks for up to 6 months or observation, with progression-free survival as the primary endpoint. Median PFS was not reached with toripalimab versus 14.1 months with observation (HR 0.55, 95% CI 0.31-0.96), and median OS was not reached versus 30.3 months (HR 0.39, 95% CI 0.19-0.80). The authors concluded that consolidative toripalimab showed promising PFS and OS signals with manageable safety, warranting confirmation in larger trials.
10.1136/jitc-2026-016467
Felzartamab plus lenalidomide-dexamethasone versus lenalidomide-dexamethasone for relapsed or refractory multiple myeloma: an open-label, parallel-controlled, randomised, phase 3 trial.
LANCET HAEMATOL · Q1 JOURNAL - RANK #3/98TOP-TIER
This open-label, parallel-controlled, randomised phase 3 trial evaluated felzartamab plus lenalidomide-dexamethasone versus lenalidomide-dexamethasone in 295 Chinese adults with relapsed or refractory multiple myeloma. Patients were randomised 2:1 to receive felzartamab (16 mg/kg intravenously) plus lenalidomide-dexamethasone (n=195) or lenalidomide-dexamethasone alone (n=100), with progression-free survival as the primary endpoint. At median follow-up of 34.5 vs 28.7 months, median progression-free survival was 18.9 vs 10.4 months (HR 0.62, 95% CI 0.45-0.86; p=0.0035). Felzartamab plus lenalidomide-dexamethasone significantly prolonged progression-free survival, supporting this combination as a potential new treatment option, though grade 3-4 adverse events and treatment-related deaths were more frequent with felzartamab.
10.1016/S2352-3026(26)00223-1
A Phase I Clinical Trial of Chemoimmunotherapy with Alternating Intravesical Gemcitabine and Bacillus Calmette-Guérin (GemBCG) for BCG-Exposed High-Grade Non-Muscle-Invasive Bladder Cancer.
J UROLOGY · Q1 JOURNAL - RANK #10/133
This Phase I dose-escalation trial evaluated intravesical chemoimmunotherapy with gemcitabine and BCG (GemBCG) in 25 patients with BCG-exposed high-grade non-muscle-invasive bladder cancer. The primary objective was to define the maximally tolerated dose using a modified continual reassessment method, with gemcitabine escalated from 500-2000 mg and BCG given at 50 mg TICE. No treatment-related grade ≥3 adverse events or dose-limiting toxicities occurred, and 24 of 25 patients (96%; 95% CI 80%-100%) achieved a complete clinical response at 6-months. The authors conclude that GemBCG was safe, well-tolerated, and demonstrated promising early efficacy with immune microenvironment modification.
10.1097/JU.0000000000005324
A Phase II Study of Nivolumab and Ipilimumab with Radiation Therapy in Patients with Metastatic, Microsatellite Stable Colorectal Cancer.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This multicenter, open-label, single-arm Phase II trial evaluated combined non-ablative radiation therapy with nivolumab and ipilimumab in 30 patients with previously treated microsatellite stable metastatic colorectal cancer. The primary endpoint was objective response rate in unirradiated lesions, which was 10.0%, with disease control rate 33.3%; irradiated lesions showed ORR 13.3% and DCR 83.3%. Responses were higher in patients without liver metastases (25.0%) versus those with liver metastases (4.6%), with median PFS of 2.4 months and median OS of 12.8 months. The combination demonstrated selective clinical activity and acceptable toxicity, with grade 4 lymphopenia in 10% of patients.
10.1158/1078-0432.CCR-26-1261
Efficacy of everolimus and letrozole with or without ribociclib in recurrent endometrial cancer: a phase 2 randomized clinical trial.
NAT COMMUN · Q1 JOURNAL - RANK #10/135TOP-TIER
This phase 2 randomized clinical trial evaluated the efficacy of adding ribociclib to everolimus/letrozole in patients with recurrent endometrial cancer, randomizing participants to experimental (ribociclib combination) or control (everolimus/letrozole alone) arms, with progression-free survival as the primary endpoint. Among all-comers, no significant differences were observed in PFS (HR 0.78, 95% CI 0.4-1.4, p=0.38), OS (HR 0.8, 95% CI 0.4-1.5, p=0.46), ORR (44.1% vs 25.7%, p=0.11), or toxicity-related discontinuation (8.6% vs 11.4%, p=0.22). However, patients with prior endocrine therapy showed significantly higher ORR in the experimental arm (61.5% vs 0.0%, p<0.001), and within the experimental arm, CTNNB1 tumors were associated with improved PFS (HR 0.27, p=0.006) and OS (HR 0.24, p=0.004). The authors conclude that despite no survival benefit in all-comers, adding ribociclib may improve efficacy in prior endocrine therapy patients and CTNNB1 tumors may predict prolonged response.
10.1038/s41467-026-77049-3
Neoadjuvant Anlotinib Plus Paclitaxel-Cisplatin for Technically Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma: A Prospective Single-Arm Phase II Study.
HEAD NECK-J SCI SPEC · Q1 JOURNAL - RANK #15/67
This prospective, single-arm Phase II trial evaluated short-course neoadjuvant anlotinib plus paclitaxel-cisplatin in 21 patients with technically resectable locally advanced head and neck squamous cell carcinoma, administering two 21-day cycles with RECIST 1.1 objective response rate as the primary endpoint. The objective response rate was 66.7% (14/21; 95% CI, 43.0%-85.4%), meeting the prespecified activity criterion, with 8 patients undergoing surgery. Among surgical patients, all achieved R0 resection, 5/8 achieved major pathological response, and 4/8 underwent less extensive resection than initially planned, while adverse events were mainly Grade 1 with one Grade 1 hypertension and one Grade 2 primary-tumor bleeding event. The authors conclude the regimen generated antitumor activity and surgical feasibility signals but does not establish anlotinib benefit beyond TP or functional preservation.
10.1002/hed.70501
Full enrollment results from cohort 1 of the phase III randomized THOR trial of erdafitinib versus chemotherapy in FGFR-altered advanced urothelial carcinoma.
ESMO OPEN · Q1 JOURNAL - RANK #36/326
This phase III randomized THOR trial evaluated erdafitinib versus investigator-choice chemotherapy (docetaxel or vinflunine) in 278 adults with metastatic urothelial carcinoma harboring susceptible FGFR3/2 alterations who progressed after anti-PD-(L)1 therapy. Patients were randomized 1:1, with overall survival as the primary endpoint and progression-free survival and objective response rate as key secondary endpoints. At final analysis (median follow-up 21.0 vs 18.0 months), erdafitinib significantly improved median OS (12.1 vs 8.7 months; HR 0.65, 95% CI 0.48–0.86; P=0.0031), PFS (5.4 vs 2.7 months; HR 0.59, 95% CI 0.45–0.77; P<0.0001), and ORR (46.9% vs 12.6%; RR 3.74, 95% CI 2.31–6.04; P<0.001). Grade 3–4 treatment-emergent adverse events were similar (67.6% vs 65.8%), but erdafitinib had fewer treatment-related serious AEs (12.7% vs 24.8%), treatment-related deaths (0.7% vs 6.0%), and discontinuations (9.2% vs 14.5%).
10.1016/j.esmoop.2026.108583
Immunometabolic effects of oral testosterone for castration-resistant prostate cancer in the ACROBAT trial.
MOL CANCER RES · Q1 JOURNAL - RANK #77/326
This prospective clinical trial evaluated the immunometabolic effects of high-dose oral testosterone undecanoate in 10 patients with castration-resistant prostate cancer (CRPC) enrolled in the ACROBAT trial. The study performed longitudinal plasma metabolomic profiling and high-dimensional immune cell phenotyping to assess treatment response and resistance mechanisms. Results showed that testosterone exposure increased circulating metabolites within the arginine-ornithine-polyamine axis, including guanidoacetic acid, creatine, homoarginine, and N1-acetylspermidine, with non-responders exhibiting elevated polyamines such as putrescine. The study concluded that high-dose testosterone therapy increases polyamine synthesis, which is associated with therapy resistance and abundance of immunosuppressive myeloid cells, providing clinical evidence for metabolic reprogramming as a resistance mechanism.
10.1158/1541-7786.MCR-26-0573
Forimtamig, a GPRC5DxCD3 bispecific antibody with a novel 2:1 format, in relapsed/refractory multiple myeloma.
BLOOD ADV · Q1 JOURNAL - RANK #13/98
This Phase 1 prospective clinical trial evaluated subcutaneous forimtamig, a novel GPRC5DxCD3 bispecific antibody with a 2:1 configuration, in 171 patients with relapsed/refractory multiple myeloma. The study employed dose-escalation followed by backfilling at optimized target doses using weekly and condensed step-up schedules to assess safety, tolerability, and determine the maximum tolerated dose and recommended Phase 2 dose. Dose-limiting toxicities occurred in 11.7% of patients, cytokine release syndrome in 75.4%, and the maximum tolerated dose was not identified, with dose-escalation concluding at 7.2 mg due to accumulating toxicity. The overall response rate was 59.6%, reaching 71.7% with the condensed schedule at optimized doses, demonstrating potent activity but a narrow therapeutic window due to on-target off-tumor toxicities.
10.1182/bloodadvances.2026020498
Giredestrant plus Everolimus in Advanced Breast Cancer.
NEW ENGL J MED · Q1 JOURNAL - RANK #2/332TOP-TIER
This phase 3, open-label, randomized trial evaluated giredestrant plus everolimus versus standard endocrine therapy plus everolimus in patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer who progressed after CDK4/6 inhibitor plus endocrine therapy. Among 373 randomized patients, 207 had ESR1-mutated tumors; median progression-free survival was 10.0 vs 5.5 months (HR 0.38; 95% CI 0.27-0.54; P<0.001) in that subgroup and 8.8 vs 5.5 months (HR 0.56; 95% CI 0.44-0.71; P<0.001) overall. Adverse events occurred in 98.9% vs 96.8%, with stomatitis, diarrhea, and anemia most common. The all-oral giredestrant-everolimus regimen significantly prolonged progression-free survival, mainly in ESR1-mutated tumors, with similar toxicity to standard therapy-everolimus.
10.1056/NEJMoa2602457
Anterior tumour location as a risk factor for local recurrence after laparoscopic surgery for stage I ultra-low rectal cancers: exploratory analysis of the Ultimate trial.
BJS OPEN · Q1 JOURNAL - RANK #19/312
This exploratory analysis of the Ultimate trial, a multicentre prospective phase II study across 47 Japanese institutions (2014-2017), evaluated anterior tumour location as a risk factor for local recurrence after laparoscopic resection in 297 patients with stage I ultra-low rectal cancer. Patients with cT1-2 N0 M0 tumours within 5 cm of the anal verge were categorized as anterior (10-2 o’clock; n=93, 31.3%) or non-anterior (n=204). At a median follow-up of 37.2 months, the 3-year cumulative local recurrence rate was 11.9% for anterior versus 3.0% for non-anterior tumours (HR 4.46; 95% c.i. 1.67-11.89; P=0.001), with an independent association on multivariable analysis (HR 4.68; 95% c.i. 1.72-12.74). The authors conclude that anterior location in the ultra-low rectum increases local recurrence risk, particularly in cT2 patients, warranting refined treatment strategies and vigilant monitoring.
10.1093/bjsopen/zrag128
Safety and efficacy of ceralasertib, an ATR kinase inhibitor, combined with olaparib: dose escalation in advanced solid tumours and dose expansion in advanced breast cancer.
BRIT J CANCER · Q1 JOURNAL - RANK #47/326
This modular Phase 1 trial evaluated ceralasertib, an ATR inhibitor, alone and combined with olaparib in 142 patients with advanced solid tumours, including dose escalation (Part A1: ceralasertib monotherapy; Part A2: combination) and dose expansion in PARPi-naïve BRCA1/2-mutant HER2-negative breast cancer (Part B3) and BRCA1/2 wild-type triple-negative breast cancer (Part B4). The combination recommended Phase 2 dose was ceralasertib 160 mg once-daily days 1-7 plus olaparib 300 mg twice-daily continuously. Grade ≥3 treatment-emergent adverse events occurred in 43.2% and 36.0% of Parts B3 and B4, with objective response rates of 0% (Part A1), 16.4% (Part A2), 37.8% (Part B3), and 0% (Part B4). The authors concluded that ceralasertib-olaparib had manageable safety and preliminary antitumour activity in PARPi-naïve BRCA1/2-mutant HER2-negative breast cancer.
10.1038/s41416-026-03601-z
Intravenous hyaluronidase-expressing oncolytic adenovirus with chemotherapy in metastatic pancreatic cancer: a randomized phase 2b trial.
NAT MED · Q1 JOURNAL - RANK #1/195TOP-TIER
This randomized phase 2b trial evaluated intravenous hyaluronidase-expressing oncolytic adenovirus VCN-01 plus gemcitabine/nab-paclitaxel (GnP) versus GnP alone as first-line therapy in metastatic pancreatic ductal adenocarcinoma. In the intent-to-treat population (VCN-01+GnP n=53; GnP n=48), median overall survival was 10.6 vs 8.6 months (HR=0.69, 95% CI 0.42-1.12, P=0.196) and progression-free survival was 5.6 vs 4.6 months (HR=0.63, P=0.046). In the full analysis set (n=48 per group), median OS was 10.8 vs 8.6 months (HR=0.57, P=0.055) and PFS was 7.0 vs 4.6 months (HR=0.55, P=0.011), with the primary OS endpoint met. The authors conclude that VCN-01 combined with GnP shows promise and warrants a blinded phase 3 trial.
10.1038/s41591-026-04705-y
Carbon nanoparticle-Fe (II) complex for ferroptosis therapy in refractory solid tumors: a phase I trial.
SIGNAL TRANSDUCT TAR · Q1 JOURNAL - RANK #1/319TOP-TIER
This first-in-human, single-arm, open-label, dose-escalation phase I trial evaluated the safety, tolerability, and preliminary antitumour efficacy of a novel carbon nanoparticle-Fe (II) complex (CNSI-Fe) administered via direct intratumoral injection in 19 patients with refractory solid tumors, using a 3+3 design across five dose levels (30-150 mg). The maximum tolerated dose was not reached, with only one dose-limiting toxicity event reported in the 90 mg cohort, and common adverse events included injection site pain (89.5%), hypertension (52.6%), elevated serum iron (47.4%), and anemia (47.4%). Pharmacokinetic analysis showed rapid iron absorption (peak time 0.15-0.41 h) and clearance (half-life 1.96-5.06 h), while preliminary efficacy demonstrated an overall response rate of 10.5% and a disease control rate of 84.2%. The authors concluded that CNSI-Fe has a favorable safety profile and promising antitumour activity, supporting further phase II investigation.
10.1038/s41392-026-02929-5