Colorrectal Cancer
If it’s your first time on this website, please read the disclaimer section.
Jul 20 – Jul 27, 2026
Del immune V and microbiome restructuring in colorectal cancer surgery: a randomized double blind placebo controlled trial.
FRONT CELL INFECT MI · Q1 JOURNAL - RANK #32/163
The study aimed to evaluate the immunomodulatory and microbiome restructuring effects of Del-Immune V in colorectal cancer patients undergoing elective surgery. In this randomized, double-blind, placebo-controlled Phase I clinical trial including 39 patients (22 Del-Immune V, 17 placebo), participants received 100 mg capsules twice daily from 7-15 days presurgery until 15 days postsurgery. Results showed significant reductions in IL-6 (p=0.012), improvement in patient quality-of-life scores, and microbiome restructuring, including enrichment of short-chain fatty acid-producing genera and a reduction in cancer-associated taxa (dysbiosis index, p=0.024). The trial concluded that Del-Immune V is a safe adjunct therapy with immunomodulatory and microbiome-modulating properties, potentially enhancing recovery and long-term outcomes in colorectal cancer patients.
10.3389/fcimb.2026.1853373
Vactosertib plus pembrolizumab in patients with non-microsatellite instability-high metastatic colorectal or gastric cancer: a multicenter, phase Ib/IIa study.
NAT COMMUN · Q1 JOURNAL - RANK #10/135TOP-TIER
This multicenter, open-label, single-arm phase Ib/IIa clinical trial assessed vactosertib plus pembrolizumab in 120 patients with non-MSI-high metastatic colorectal (n=108) or gastric cancer (n=12). The primary objective was to evaluate safety and tolerability, with secondary endpoints including various efficacy outcomes; the regimen demonstrated manageable safety, with treatment-related adverse events in 70.8% of patients (pruritus and rash most common). Among colorectal cancer patients, an objective response rate of 12.6% (higher in those without liver metastases: 22.5% vs. 6.3%) and a median overall survival of 13.2 months were reported; no objective responses were observed in gastric cancer patients. The study concluded vactosertib plus pembrolizumab has clinical activity in non-MSI-high mCRC, especially in patients without liver metastases.
10.1038/s41467-026-75595-4
Jul 13 – Jul 20, 2026
Non-Armored GCC-targeting CAR-T cell therapy demonstrates significant efficacy in patients with advanced colorectal cancer.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This single-arm, open-label, phase 1 trial aimed to assess the safety, expansion, and preliminary anti-tumor efficacy of non-armored, nanobody-derived GCC-targeted CAR-T cells in twenty-four patients with heavily pretreated metastatic colorectal cancer. Participants received CAR-T cells at four dose levels (0.5×10^5, 1×10^6, 2×10^6, or 3×10^6 cells/kg), and the study measured toxicities, antitumor activity, and pharmacokinetics. The overall response rate and disease control rate were 33% and 63%, respectively, with a median progression-free survival of 57 days and median overall survival of 190 days. Despite encouraging antitumor activity and proof-of-concept for GCC as a valid target, response durability remained limited, requiring further optimization of dose, patient selection, and toxicity management.
10.1158/1078-0432.CCR-26-0854
Artificial intelligence-assisted detection and optical differentiation of colorectal lesions in Lynch syndrome surveillance (CADLY2): a multicentre, open-label, randomised controlled superiority trial.
LANCET GASTROENTEROL · Q1 JOURNAL - RANK #2/147TOP-TIER
This multicentre, open-label, randomised controlled superiority trial evaluated the efficacy of computer-aided detection (CADe) and computer-aided optical diagnosis (CADx) for colorectal lesion detection in Lynch syndrome surveillance. 757 adults with genetically confirmed Lynch syndrome were randomized to high-definition white-light colonoscopy (HD-WL) or HD-WL plus AI-assisted CADe, with the primary outcome being adenoma detection rate, and CADx diagnostic accuracy as a secondary endpoint. The adenoma detection rate was 30.9% in the HD-WL group versus 33.8% in the AI-assisted group (odds ratio 1.14 [95% CI 0.83–1.57], p=0.41), and CADx achieved a sensitivity of 85.9% and specificity of 91.4% for differentiating neoplastic from non-neoplastic lesions. The study concluded that CADe did not significantly improve adenoma detection rate compared with conventional colonoscopy in this high-risk population.
10.1016/S2468-1253(26)00163-9
Three-Year Follow-Up of the Randomized Trial Comparing Open Versus Laparoscopic Surgery for Primary Tumor Resection in Patients With Non-Curable Stage IV Colon Cancer (JCOG1107).
DIS COLON RECTUM · Q1 JOURNAL - RANK #33/312
This multicenter, open-label, randomized phase III trial evaluated non-inferiority of laparoscopic versus open primary tumor resection in symptomatic non-curable stage IV colon cancer. A total of 195 patients were randomized (95 open, 100 laparoscopic), followed by chemotherapy. Median follow-up was 24.4 months. Three-year progression-free survival was 5.3% (open) vs. 3.0% (laparoscopic) (HR 1.028, p=0.02 for non-inferiority), and three-year overall survival was 31.5% vs. 28.5% (HR 1.048). Laparoscopic surgery was concluded to be non-inferior and an acceptable option.
10.1097/DCR.0000000000004373
Dose-escalated versus Standard Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer: 9-year Results of a Randomized Phase 2 Trial.
INT J RADIAT ONCOL · Q1 JOURNAL - RANK #14/212
This prospective, randomized phase II trial (NCT02195141) in 106 patients with stage II/III rectal adenocarcinoma compared standard (50 Gy/25 fractions) and dose-escalated SIB-CRT (50 Gy to the pelvis with SIB to 56–60 Gy) before planned radical surgery. The primary endpoint was pathological complete response (pCR), with secondary outcomes including DFS, OS, MFS, LC, CSS, and toxicity. At a median follow-up of 116.6 months, the SIB-CRT group demonstrated higher 9-year DFS (70.8% vs 47.4%, HR 0.46, P=0.013), OS (74.3% vs 48.9%, HR 0.43, P=0.008), and LC (87.1% vs 70.1%, HR 0.40, P=0.038), with comparable pCR rates (15.2% vs 18.4%). These findings highlight the significant survival advantage afforded by dose escalation, especially in patients who did not receive perioperative chemotherapy.
10.1016/j.ijrobp.2026.07.004
Jul 06 – Jul 13, 2026
Aspirin for cancer prevention in individuals with Lynch syndrome: first results from the CaPP3 multicentre, randomised, double-blind, non-inferiority trial.
LANCET GASTROENTEROL · Q1 JOURNAL - RANK #2/147TOP-TIER
The CaPP3 trial assessed the efficacy of lower aspirin doses (100 mg or 300 mg daily) compared to 600 mg daily for cancer prevention in 1879 Lynch syndrome carriers across five countries, using a multicentre, double-blind, non-inferiority design. Primary outcomes measured new Lynch syndrome cancers, with non-inferiority defined as HR and IRR upper 95% CI <1.5. Results showed 100 mg was non-inferior to 600 mg in intention-to-treat analysis (HR 0.97 [0.67-1.42], IRR 0.94 [0.65-1.38]), but 300 mg failed non-inferiority (HR 1.28 [0.91-1.80], IRR 1.12 [0.79-1.61]). Adverse events increased with dose (25.0% at 100 mg vs. 31.2% at 600 mg; p=0.03), with fewer bleeding events at lower doses (0% at 100 mg vs. 1.5% at 600 mg; p=0.004). The study concluded that 100 mg aspirin may offer comparable cancer prevention with reduced side effects, though formal non-inferiority was not established for both doses.
10.1016/S2468-1253(26)00114-7
Fecal microbiome and metabolome dynamics during immunotherapy-based total neoadjuvant therapy in rectal cancer: associations with treatment response and toxicity.
FRONT IMMUNOL · Q1 JOURNAL - RANK #32/183
Investigators performed a longitudinal fecal multi-omics study in 102 samples from microsatellite-stable locally advanced rectal cancer patients receiving immunotherapy-based total neoadjuvant therapy as part of the prospective TORCH trial (NCT04518280). They integrated metagenomic sequencing and untargeted metabolomics to identify gut microbiome and metabolic changes that correlated with therapeutic response and toxicity. They found that iTNT induced significant shifts in microbial diversity and metabolic pathways, with an enrichment of Firmicutes and gamma-aminobutyric acid (GABA) associated with therapy non-response. The authors conclude that GABA may reduce antitumor efficacy of radiotherapy plus immunotherapy, offering a novel immune modulation target and potential biomarkers for treatment stratification.
10.3389/fimmu.2026.1871586
Randomized phase-II trial of surufatinib plus FOLFOX/FOLFIRI versus FOLFOXIRI as second-line therapy for metastatic colorectal cancer.
ANN MED · Q1 JOURNAL - RANK #39/332
This multicentre, open-label, randomized phase-II trial evaluated surufatinib plus FOLFOX/FOLFIRI versus FOLFOXIRI as second-line therapies for metastatic colorectal cancer, enrolling 57 patients from September 2021 to November 2023. Patients were randomized 1:1, and the primary endpoint was objective response rate (ORR); the doublet cohort (surufatinib plus mFOLFOX6/FOLFIRI) had ORR of 35.7% and median progression-free survival (PFS) of 5.4 months, while the triplet cohort (surufatinib plus FOLFOXIRI) had ORR of 39.3% and median PFS of 5.8 months. The triplet cohort experienced more grade ≥3 treatment-emergent adverse events (71.4% vs. 57.1%) and shorter median overall survival (10.9 vs. 19.0 months). The study concludes surufatinib plus doublet chemotherapy shows promising activity and manageable toxicity, while the triplet regimen is not recommended due to excess toxicity and reduced survival.
10.1080/07853890.2026.2698360
Jun 29 – Jul 06, 2026
Efficacy and safety of a novel oral anti-vasculogenic mimicry agent, CVM-1118, in advanced well-differentiated neuroendocrine tumors: a Phase IIa trial.
BRIT J CANCER · Q1 JOURNAL - RANK #47/326
This Phase IIa prospective, single-arm trial assessed foslinanib (CVM-1118), an oral anti–vasculogenic mimicry agent, in advanced well‑differentiated NETs refractory/intolerant to prior therapy. Patients (N=43; 35 efficacy‑evaluable) with grade 1–2 lung, gastrointestinal, or pancreatic NETs received CVM‑1118 200–300 mg twice daily in 28‑day cycles; primary endpoint was PFS, with ORR, DCR, OS, and safety secondary. Median PFS was 10.5 months (95% CI 5.6–22.3), ORR 3%, DCR 77%, and median OS not reached (95% CI 23.8–NR); in the full analysis set (N=43), median PFS was 8.4 months, and among those with prior everolimus, sunitinib, or PRRT (N=22), median PFS was 8.3 months. Treatment‑related AEs occurred in 44%, mostly grade 1–2, with no serious events, supporting favorable efficacy and tolerability.
10.1038/s41416-026-03515-w
Neoadjuvant toripalimab plus celecoxib versus toripalimab monotherapy for mismatch repair-deficient or microsatellite instability-high, locally advanced colorectal cancer (PICC-2): an open-label, multicentre, randomised, phase 2 trial.
LANCET ONCOL · Q1 JOURNAL - RANK #8/326TOP-TIER
This multicentre, open-label, randomised phase 2 trial (PICC-2) evaluated whether adding the COX-2 inhibitor celecoxib to neoadjuvant toripalimab enhances efficacy in adults (n=110) with mismatch-repair-deficient or MSI-high, locally advanced colorectal cancer. Patients were randomised 1:1 to receive 12 bi-weekly cycles of toripalimab 3 mg/kg with celecoxib 200 mg twice daily or toripalimab alone, followed by surgery; the primary endpoint was pathological complete response (pCR) assessed by blinded central pathology in the intention-to-treat population. pCR occurred in 89% (49/55) of combination patients versus 69% (38/55) of monotherapy patients, an absolute difference of 19 percentage points (95% CI 4–34; p=0.014); grade 3 treatment-related adverse events were infrequent (5% vs 7%), with no grade 4/5 events. The authors conclude that adding celecoxib to PD-1 blockade significantly improves pCR without increasing serious toxicity, warranting phase 3 confirmation.
10.1016/S1470-2045(26)00220-2
ELECLA trial: final results of perioperative chemotherapy with fluoropyrimidine and oxaliplatin in mismatch repair proficient locally advanced colon cancer.
ESMO OPEN · Q1 JOURNAL - RANK #36/326
The ELECLA trial evaluated the safety and efficacy of neoadjuvant chemotherapy (NAC) with fluoropyrimidine and oxaliplatin in mismatch repair proficient locally advanced colon cancer (LACC) through a multicenter, randomized, open-label, phase II controlled trial. Patients (n=120) were randomized to NAC followed by surgery and adjuvant chemotherapy (AC) or upfront surgery plus AC, with a primary endpoint of 2-year disease-free survival. NAC achieved significant tumor downstaging (65.4% volume reduction, P<0.001) and improved pathological features (e.g., 0% incomplete resections vs. 7.4% in controls, P=0.068), with comparable 2-year survival (88.9% vs. 83.3%, P=0.34). The study concluded that NAC is safe, feasible, and enhances tumor response without increasing perioperative morbidity, supporting its use in LACC.
10.1016/j.esmoop.2026.108250
Perioperative systemic therapy versus surgery alone for resectable colorectal peritoneal-only metastases (CAIRO6): a randomised, open-label, phase 3 trial.
LANCET ONCOL · Q1 JOURNAL - RANK #8/326TOP-TIER
This multicenter randomized, open-label phase 3 trial compared perioperative systemic therapy plus cytoreductive surgery with HIPEC versus upfront surgery alone in adults with resectable colorectal peritoneal-only metastases. In the modified intention-to-treat population (n=351; 173 therapy, 178 surgery), patients received CAPOX, FOLFOX, or FOLFIRI with bevacizumab in neoadjuvant cycles and capecitabine or 5-FU/leucovorin adjuvantly; the primary endpoint was overall survival with median follow-up of 41 months. Median overall survival was 44 months with perioperative therapy versus 39 months with surgery alone (HR 0.85, 95% CI 0.62–1.15; p=0.28), major 90-day postoperative morbidity was 36% versus 26%, grade 3–4 systemic toxicity occurred in 57% of treated patients, and 90-day mortality was 1% in each arm. Investigators concluded perioperative systemic therapy cannot be recommended universally for resectable colorectal peritoneal-only metastases.
10.1016/S1470-2045(26)00085-9
Longitudinal single-cell and TCR repertoire profiling characterizes clonal entrapment in patients with pMMR/MSS locally advanced rectal cancer.
CELL DISCOV · Q1 JOURNAL - RANK #19/204TOP-TIER
This prospective study, part of clinical trial NCT06493240, analyzed paired single-cell RNA and TCR sequencing from longitudinally collected tumor biopsies and blood samples from 20 pMMR/MSS locally advanced rectal cancer patients receiving sequential radiotherapy and ICI therapy. The key finding was that elevated baseline immune inflammation paradoxically predicted worse outcomes, explained by ‘clonal entrapment’ where increased HLA-DQA2 in dendritic cells and GDF15 in tumor cells limited expansion of novel tumor-reactive TCR clonotypes. The immune response was restricted largely to pre-existing TCR clonotypes from the CD8 T cell pool, particularly those expanded under chronic inflammation. The authors conclude this offers a high-resolution framework for understanding resistance to this combined therapy.
10.1038/s41421-026-00900-w
A phase II study of alpelisib and capecitabine in patients with previously treated metastatic colorectal cancer (KCSG-CO21-04).
SCI REP-UK · Q1 JOURNAL - RANK #25/135
This open-label, single-arm, multi-center phase II study assessed the combination of alpelisib and capecitabine in 26 patients with PIK3CA-mutant metastatic colorectal cancer who progressed after standard chemotherapy. Participants received both drugs orally in 21-day cycles, with clinical outcomes and serial circulating tumor DNA evaluated longitudinally. Median progression-free and overall survival were 3.5 and 8.8 months, respectively, with two partial responders, and more than half demonstrating disease control. Although the combination showed modest antitumor activity, frequent hyperglycemia and other toxicities necessitated dose modifications, highlighting the need for improved toxicity management and patient selection.
10.1038/s41598-026-57970-9
Jun 22 – Jun 29, 2026
Patient-led, home-based follow-up for colorectal cancer: the DISTANCE multicentre stepped-wedge cluster-randomised trial.
BJS-BRIT J SURG · Q1 JOURNAL - RANK #5/312
The DISTANCE trial is a prospective, stepped-wedge cluster-randomised interventional study evaluating patient-led, home-based follow-up (PHFU) versus standard hospital-based follow-up for 354 stage I-III colorectal cancer survivors in six Dutch hospitals. The primary outcome was hospital contacts; secondary outcomes included quality of life (EORTC QLQ-C30), cancer-related worry (CWS), and psychological distress (HADS). In the as-treated analysis, PHFU reduced hospital contacts by 38% (RR 0.62, 95% CI 0.51-0.75, p<0.001), with no significant differences in QoL or distress. The authors conclude PHFU is feasible and effective, though substantial crossover (117/354) occurred.
10.1093/bjs/znag081
Assessment of 16S rRNA sequencing for analysis of circulating microbial DNA in colorectal cancer patients-proof of concept and early changes during experimental chemoimmunotherapy.
FRONT MICROBIOL · Q1 JOURNAL - RANK #38/163
This prospective study examined the feasibility of 16S rRNA sequencing to characterize circulating microbial DNA in colorectal cancer (CRC) patient samples. Researchers analyzed plasma and serum from two cohorts, including 11 early-stage colon cancer patients and 11 metastatic CRC patients undergoing alternating oxaliplatin-based chemotherapy and nivolumab. Findings revealed that while both plasma and serum were suitable for cmDNA profiling, plasma provided higher bacterial reads, and non-responsive patients showed significant increases in alpha diversity (p=0.014, p=0.010, p=0.004) prior to treatment failure. Overall, the results highlight cmDNA as a promising non-invasive biomarker for chemoimmunotherapy effectiveness.
10.3389/fmicb.2026.1802448
Mutant KRAS peptide vaccine with dual checkpoint blockade in metastatic colorectal cancer: a phase I trial.
NAT COMMUN · Q1 JOURNAL - RANK #10/135TOP-TIER
The primary objective of this single-arm phase I clinical trial was to evaluate the safety and immunogenicity of a pooled mutant KRAS peptide vaccine (mKRAS-VAX) combined with nivolumab and ipilimumab in 13 patients with pretreated metastatic mismatch repair proficient/microsatellite stable colorectal cancer. Safety and immunogenicity endpoints were met within 17 weeks, with all vaccine-attributed adverse events graded as 1 or 2, and no increased severe immune-related events beyond dual ICIs. Immunogenicity was demonstrated by an increase in tumor-specific mKRAS-reactive T-cells in 8/12 patients by direct ex vivo IFNγ ELISpot (75%) and in all patients (100%) following in vitro expansion. The principal conclusion is that mKRAS-VAX in combination with ICIs is safe, immunogenic, and warrants further clinical development.
10.1038/s41467-026-74711-8
Efficacy of hydrocolloid dressing for hand-foot skin reaction: J-SUPPORT 1701 APRON trial.
SUPPORT CARE CANCER · Q1 JOURNAL - RANK #17/173
This phase 3 randomized self-controlled study evaluated the efficacy of hydrocolloid dressing versus standard prophylactic moisturizing alone in preventing hand-foot skin reaction (HFSR) among 50 patients with unresectable colorectal cancer, gastrointestinal stromal tumors, or hepatocellular carcinoma receiving regorafenib or sorafenib. The primary endpoint was incidence of grade 2 or higher HFSR, assessed with blinded central review and patient-reported outcomes. Results showed a significantly lower rate of grade 2 or higher HFSR in the hydrocolloid group versus control (20% vs. 50%, p < 0.0001; HR for time to event 0.32, p = 0.0017) and reduced patient-reported moderate to severe HFSR (10% vs. 32%, p = 0.0002). The authors concluded that hydrocolloid dressings provide effective prophylaxis for HFSR in this population.
10.1007/s00520-026-10902-9
Effect of prior anti-EGFR therapy and baseline ctDNA profiling on the efficacy of pertuzumab plus trastuzumab in HER2-amplified metastatic colorectal cancer: an integrated analysis of TRIUMPH/MyPathway.
ESMO OPEN · Q1 JOURNAL - RANK #36/326
This integrated analysis evaluated the effect of prior anti-EGFR therapy and baseline circulating tumor DNA (ctDNA) profiling on the efficacy of pertuzumab plus trastuzumab in HER2-amplified metastatic colorectal cancer, using patient-level data from the prospective TRIUMPH and MyPathway clinical trials. The study analyzed 66 patients with HER2-amplified mCRC, stratified by prior anti-EGFR therapy and ctDNA-detected resistance alterations, examining outcomes including overall survival and response rates. Results showed that prior anti-EGFR therapy was linked to inferior overall survival (median: 10.9 vs 19.7 months; HR: 2.01) and no objective responses were observed in patients with anti-EGFR resistance alterations as detected by ctDNA (0% vs 31.3%), with shorter OS (7.6 vs 16.5 months; HR: 2.15). The study concludes that both prior anti-EGFR therapy and ctDNA resistance alterations predict reduced benefit from HER2-targeted therapy, highlighting the value of integrated patient selection.
10.1016/j.esmoop.2026.107734
Pooled analysis of 2 clinical trials of first-line chemoimmunotherapy for metastatic microsatellite stable colorectal cancer MEDITREME and METIMMOX studies.
ONCOIMMUNOLOGY · Q1 JOURNAL - RANK #51/326
This pooled analysis evaluated two phase II trials—MEDITREME (single-arm: durvalumab/tremelimumab plus oxaliplatin-based chemotherapy) and METIMMOX (randomized: alternating nivolumab plus chemotherapy versus chemotherapy alone)—as first-line treatments for metastatic microsatellite stable colorectal cancer. Across 130 patients (92 chemoimmunotherapy, 38 chemotherapy alone), the median overall survival favored the chemoimmunotherapy group (not reached vs. 15.3 months; HR=0.58; 95% CI 0.36-0.96; p=0.03), with complete response rates of 14% versus 5%. Progression-free survival did not significantly differ between groups. The analysis found high baseline CD8 T-cell infiltration correlated with improved chemoimmunotherapy outcomes, identifying a potential predictive biomarker.
10.1080/2162402X.2026.2671491
Jun 15 – Jun 22, 2026
Safety and Efficacy of a Sandwich Total Neoadjuvant Therapy Strategy for Low-Risk Distal Locally Advanced Rectal Cancer: Results From the TESS Phase II Trial.
MEDCOMM · Q1 JOURNAL - RANK #14/195TOP-TIER
This prospective phase II multicenter trial tested a novel sandwich total neoadjuvant therapy (TNT) in 98 patients with low-risk distal locally advanced rectal cancer. The intervention involved two cycles of capecitabine and oxaliplatin before, during, and after radiation, followed by surgery or a watch-and-wait approach, plus two adjuvant capecitabine cycles. The primary endpoint was cCR (46.9% ITT), alongside 89.5% local regrowth-free survival and 96.9% overall survival. The findings indicate high cCR, pCR, and organ preservation rates, suggesting a promising approach for selected patients.
10.1002/mco2.70807
Effect of a multimodal bundled intervention on quality of recovery after laparoscopic colorectal cancer surgery: a single-center, single-blind, pragmatic randomized controlled trial.
WORLD J SURG ONCOL · Q1 JOURNAL - RANK #70/312
This single-center, single-blind, parallel-group, pragmatic randomized controlled trial examined whether a multimodal bundled intervention (electroacupuncture, abdominal massage, structured breathing training, and supervised ambulation) plus standard care improves post-laparoscopic surgery recovery in 105 patients with stage I-III colorectal cancer. Participants were randomized to the intervention or standard care alone, and the primary outcome was Quality of Recovery-15 (QoR-15) score measured at postoperative days 3, 7, and 30. A group-by-time interaction was found significant (P=0.043) with no differences at days 3 or 7 but a higher QoR-15 in the intervention group on day 30 (mean difference 11.33; 95% CI 3.41 to 19.26; P=0.005). These results suggest a clinically meaningful medium-term recovery improvement but not accelerated early recovery after laparoscopic colorectal cancer surgery.
10.1186/s12957-026-04454-9
Tumor regression pattern and distribution of residual tumor cells in potential candidates for local excision of rectal cancer: a prospective cohort study.
TECH COLOPROCTOL · Q1 JOURNAL - RANK #54/312
This prospective cohort study analyzed 40 patients with extraperitoneal T3/T4 rectal adenocarcinoma treated with radiotherapy (5x5 Gy) and CAPOX chemotherapy, aiming to characterize tumor regression patterns and residual tumor cell (RTC) distribution for local excision candidacy. The study classified regression as solid or fragmented, measured microscopic intramural spread (MIS), and developed a four-type RTC distribution model (luminal, invasive front, concentric, random). Among the 19 (47.5%) ypT0-2 tumors, fragmented pattern occurred in only two ypT2 cases (10.5%), MIS was present in four ypT2 cases (21.0%) with maximum extension 8 mm, and RTC type I (luminal) distribution was found in 16 cases (84.2%). The authors concluded that ypT0-2 cases predominantly show solid regression, no MIS, and no lymph node involvement, potentially guiding resection margins and surgical technique selection.
10.1007/s10151-026-03373-x
Two-Year Outcomes after Direct-to-Surgery in Good Prognosis Margin-Clear Stage II or III Rectal Cancer: The QuickSilver Study.
ANN SURG ONCOL · Q1 JOURNAL - RANK #39/312
The QuickSilver Study is a prospective, non-randomized, phase II trial conducted at 12 Canadian hospitals to evaluate a direct-to-surgery approach for patients with ‘margin-clear’ Stage II or III rectal cancer based on magnetic resonance imaging (MRI) staging. Of 139 patients recruited, 80 with Stage II/III rectal cancer experienced 2-year local recurrence, disease-free survival, and overall survival rates of 1% (95% CI 0-6.8), 85% (95% CI 75.3-92.0), and 99% (95% CI 93.2-100), respectively. Only 8% of these patients received adjuvant radiotherapy, while 51% of Stage I patients were over-staged on MRI as Stage II/III. The study concludes that patients meeting MRI ‘good prognosis’ criteria may safely undergo a direct-to-surgery approach with low recurrence risk and minimal radiation use.
10.1245/s10434-026-19991-6
Efficacy and safety of TiaoPi AnChang decoction to reduce CAPOX-Induced adverse reactions in Chinese patients with colorectal cancer: a randomized, double-blind, placebo-controlled trial.
FRONT PHARMACOL · Q1 JOURNAL - RANK #51/352
This randomized, double-blind, placebo-controlled trial evaluated the efficacy of TiaoPi AnChang Decoction (TPACD) for reducing CAPOX-induced adverse reactions (CIARs) and improving survival in Chinese colorectal cancer patients. A total of 108 high-risk stage II or III CRC patients were assigned to TPACD (n=54) or placebo (n=54) for 4 chemotherapy cycles, with endpoints including CIARs (CTCAE-graded), TCM syndrome scores, QoL, immune cell subsets, tumor markers, safety, and survival outcomes. The TPACD group had significantly lower grade ≥2 CIARs (37.77% vs. 67.70%, p=0.008), improved QoL (LSMD -11.71, p<0.001), enhanced CD4+/CD8+ ratio (2.64±1.04 vs. 1.91±0.94, p=0.002), and no added hepatic or renal injury. Survival outcomes were not yet mature, but TPACD was concluded to be effective and safe as a complementary therapy.
10.3389/fphar.2026.1707147
Jun 08 – Jun 15, 2026
Chemoimmunotherapy enables adaptive strategies in locally advanced MSS colorectal cancer.
MED-CAMBRIDGE · Q1 JOURNAL - RANK #11/195TOP-TIER
This study evaluated a prospective human clinical trial of chemoimmunotherapy in patients with locally advanced MSS colorectal adenocarcinoma. The intervention involved 3-month preoperative cadonilimab (bispecific anti-PD-1/CTLA-4 antibody) combined with modified FOLFOXIRI triplet intensive chemotherapy. Key findings included promising pathological activity and hints of radiotherapy-sparing and organ preservation outcomes. The conclusions suggest that chemoimmunotherapy may enable adaptive strategies in this difficult-to-treat cancer population, though specific numerical results were not provided in the abstract.
10.1016/j.medj.2026.101145
The phase I trial of preoperative short-course chemoradiotherapy with S-1/irinotecan and short-course radiation in locally advanced lower rectal cancer (SHOWTIME study).
RADIAT ONCOL · Q1 JOURNAL - RANK #51/212
This phase I prospective clinical trial aimed to determine the optimal irinotecan dose (maximum tolerated dose and recommended dose) in a short-course chemoradiotherapy regimen combining S-1/irinotecan and short-course radiation for locally advanced rectal cancer. Fifteen patients received escalating doses of irinotecan (40–60 mg/m²) alongside S-1 and a radiotherapy course (25 Gy in 5 fractions); dose-limiting toxicity assessment was performed over 14 days. At 60 mg/m², all patients experienced DLT, while at 50 mg/m², two out of six experienced DLT, and 50 mg/m² was established as the recommended dose. Key findings included a 100% R0 resection rate, 27.3% pathological complete response, 90.9% downstaging, and the regimen was deemed safe and feasible for further study.
10.1186/s13014-026-02872-3
Colonoscopy versus biennial FIT screening: a post hoc sustained-strategy analysis of the COLONPREV Trial.
GUT · Q1 JOURNAL - RANK #4/147TOP-TIER
This study is a post hoc per-protocol analysis of the COLONPREV Trial, a pragmatic colorectal cancer screening trial comparing one-time colonoscopy versus sustained biennial FIT screening among 17,270 screening initiators aged 50-69 in Spain. The analysis used inverse probability weighting to adjust for confounding and informative protocol deviations. Weighted 10-year risks were similar for CRC incidence (FIT 0.80% vs colonoscopy 0.86%; RD 0.06%, 95% CI -0.25% to 0.37%) and all-cause mortality (4.02% vs 4.09%; RD 0.07%, 95% CI -0.76% to 0.84%), while CRC mortality showed imprecise lower risk with colonoscopy (0.072% vs 0.042%; RD -0.03%, 95% CI -0.12% to 0.06%). The conclusions emphasize that sustained colonoscopy and FIT yield similar outcomes, highlighting adherence’s importance in pragmatic screening trials.
10.1136/gutjnl-2026-338896
Guanylyl Cyclase 2C-Targeted Chimeric Antigen Receptor T-Cell Therapy in Patients With Metastatic Colorectal Cancer.
J CLIN ONCOL · Q1 JOURNAL - RANK #6/326TOP-TIER
This open-label, single-center, phase I clinical trial evaluated the safety and efficacy of GUCY2C-targeted CAR T-cell therapy in 20 patients with metastatic colorectal cancer. The study involved a 3 + 3 dose-escalation design testing four CAR T-cell doses, followed by dose expansion at DL3. The objective response rate was 26.3% overall (40.0% in DL3) and median progression-free survival in DL3 was 7.0 months, with acceptable safety—one patient had grade 3 cytokine release syndrome/neurotoxicity and 11 had grade 3 diarrhea. The results indicate dose-dependent efficacy, especially in patients with medium-to-high GUCY2C expression.
10.1200/JCO-25-01090
Post-adjuvant chemotherapy in ctDNA-positive patients with resected colorectal cancer: a randomized phase 3 trial.
NAT MED · Q1 JOURNAL - RANK #1/195TOP-TIER
This randomized, double-blind phase 3 trial (ALTAIR; NCT04457297) tested whether initiating trifluridine/tipiracil (FTD/TPI) upon molecular recurrence detected by tumor-informed circulating tumor DNA improves outcomes after curative resection of stage 0-IV colorectal cancer. Two hundred forty-three ctDNA-positive, radiologically disease-free patients were randomized 1:1 to FTD/TPI or placebo for six months; the primary endpoint was investigator-assessed disease-free survival (DFS). Median DFS was 9.30 months with FTD/TPI versus 5.55 months with placebo (hazard ratio 0.79, 95% CI 0.60-1.05; P = 0.107), failing to reach statistical significance; grade ≥3 hematologic adverse events occurred in 73.0% versus 3.3%, respectively. The authors conclude that post-adjuvant intervention with FTD/TPI did not significantly prolong DFS despite increased toxicity, questioning the benefit of early treatment initiation based on ctDNA positivity alone.
10.1038/s41591-026-04428-0
Diabetes and Performance Status Predict Severe, Persistent Radiation Proctitis: Long-Term Endoscopic Findings From STELLAR Trial.
INT J RADIAT ONCOL · Q1 JOURNAL - RANK #14/212
This secondary analysis of the STELLAR trial evaluated long-term endoscopic outcomes of chronic radiation proctitis (CRP) in 74 locally advanced rectal cancer patients after neoadjuvant therapy, comparing short-course radiation/TNT (n=39) to long-course chemoradiation (n=35). Systematic endoscopic follow-up beyond 2 years used the Vienna Rectoscopy Score (VRS), with multivariate analysis identifying predictors of severe (VRS≥3) and persistent severe CRP. Incidence of severe CRP was 33.3% in TNT versus 20.0% in CRT (P=0.197); diabetes was an independent risk factor for severe CRP (HR=5.46, 95% CI 1.25-23.89, P=0.024) and persistent severe CRP (HR=6.09, 95% CI 1.23-30.23, P=0.027), while ECOG performance status 1 predicted persistent severe CRP (HR=8.81, 95% CI 1.50-51.68, P=0.016). The authors conclude that diabetes and reduced performance status strongly predict severe and persistent radiation proctitis, enabling risk-stratified surveillance.
10.1016/j.ijrobp.2026.05.004
Jun 01 – Jun 08, 2026
Design and preliminary report of a randomized phase IIb clinical trial of multitargeted recombinant adenovirus 5 vaccines against CEA, MUC1, and brachyury (Tri-Ad5) and the IL-15 receptor superagonist nogapendekin alfa inbakicept in Lynch syndrome (TRIAD5-Plus): the first cross-network trial of the Cancer Prevention Clinical Trials Network (CP-CTNet).
FRONT IMMUNOL · Q1 JOURNAL - RANK #32/183
This ongoing phase IIb clinical trial aims to determine whether a combination of Tri-Ad5, a vaccine targeting CEA, MUC1, and brachyury, plus the IL-15 receptor superagonist nogapendekin alfa-inbakicept (NAI) reduces colorectal neoplasm incidence in Lynch syndrome. It includes an initial two-phase open-label safety assessment followed by a randomized controlled trial with 138 participants scheduled to receive either Tri-Ad5+NAI or placebo. Preliminary safety data from 20 participants (median age 57.5) showed 139 and 178 adverse events across two safety phases, predominantly grade 1, including grade 3 rash in 100% of those receiving NAI but without serious treatment-related events. The interim results indicate that Tri-Ad5+NAI is well-tolerated, and final analyses will assess efficacy in preventing colorectal neoplasms at 52 and 104 weeks.
10.3389/fimmu.2026.1809281
Colonic resection or self-expanding metal stents for obstructive left colon cancer: results of a national multicenter prospective cohort study (CROSCO-1).
SURG ENDOSC · Q1 JOURNAL - RANK #64/312
The CROSCO-1 study compared emergency surgery (ES) versus self-expanding metal stents (SEMS) as a bridge to surgery (BtS) in 216 patients with obstructive left-sided colon cancer, assessing safety, efficacy, and quality-of-life outcomes. This national multicenter prospective observational cohort study in Italy (NCT05801211) found SEMS/BtS significantly lowered 1-year stoma rates (44.4% vs 73.4%, adjusted OR 3.74 for ES; p=0.016) and reduced 30-day readmissions (4.2% vs 15.9%) while enabling earlier chemotherapy initiation (76.1% vs 55.8%; p=0.003). Quality of life (EQ-5D-5L) was superior in the SEMS/BtS group, with comparable short-term morbidity/mortality. The study concludes SEMS/BtS offers clinical and quality-of-life benefits, advocating for tailored use in experienced centers.
10.1007/s00464-026-12929-9
Impact of Intravenous Lidocaine, Dexmedetomidine, and Intrathecal Morphine on Metastasis-Related Biomarkers and Cellular Immune Profiles in Colorectal Surgery: A Prospective, Randomized Controlled Trial.
ANESTH ANALG · Q1 JOURNAL - RANK #9/68
This prospective, randomized, patient- and assessor-blinded trial investigated the effects of intravenous lidocaine, dexmedetomidine, or intrathecal morphine on metastasis-related biomarkers (MMP-9, MMP-2, VEGF, IL-6) and immune cell subsets in patients undergoing laparoscopic or robotic colorectal cancer surgery. Plasma MMP-9 at 1 hour postoperatively served as the primary endpoint, with secondary analyses examining T and NK cell subsets, CD39/CD73 expression, and clinical outcomes such as pain and opioid use. Lidocaine was associated with higher MMP-9 (difference from DEX: 0.333; 95% CI, 0.0642–0.601; P=0.009), dexmedetomidine influenced T-cell phenotypes, and intrathecal morphine provided superior analgesia. The authors concluded that anesthetic adjuvants differently modulate immune responses and tumor-promoting pathways, highlighting potential implications for future oncologic outcomes.
10.1213/ANE.0000000000007978
Chemotherapy for patients with circulating tumour DNA positive, stage II colon cancer (CIRCULATE) - an AIO / ABCSG trial.
ANN ONCOL · Q1 JOURNAL - RANK #4/326TOP-TIER
This prospective multi-center trial aimed to evaluate the role of adjuvant chemotherapy for ctDNA-positive stage II colon cancer using an academic tumor-informed NGS-based test. Patients with ctDNA positivity were randomized 2:1 to receive chemotherapy (capecitabine ± oxaliplatin) or observation, while ctDNA-negative patients were also randomized to observation or off-study. Despite early study termination, the per-protocol results revealed improved time-to-recurrence and disease-free survival with chemotherapy in ctDNA-positive patients (3-year recurrence: 19% vs 62%, HR 0.23, P=0.009). Although the primary ITT endpoint was not met, these data support using ctDNA testing to guide adjuvant therapy decisions in stage II colon cancer.
10.1016/j.annonc.2026.05.001
A randomised study of encorafenib, cetuximab, and FOLFIRI versus FOLFIRI with or without bevacizumab in BRAF V600E-mutant colorectal cancer: BREAKWATER Cohort 3.
ANN ONCOL · Q1 JOURNAL - RANK #4/326TOP-TIER
The randomized phase of the BREAKWATER trial (Cohort 3) evaluated first-line encorafenib plus cetuximab with FOLFIRI versus FOLFIRI ± bevacizumab in 147 patients with previously untreated BRAF V600E-mutant metastatic colorectal cancer. Patients were assigned 1:1, and outcomes were assessed by blinded independent central review; primary endpoint was objective response rate (ORR), with progression-free survival (PFS), overall survival (OS), and safety as secondary endpoints. EC+FOLFIRI significantly improved ORR (64.4% vs 39.2%; OR 2.76, 95% CI 1.42-5.35; P = 0.0011) and PFS (median 15.2 vs 8.3 months; HR 0.44, 95% CI 0.27-0.70; P = 0.0002), and showed prolonged OS (HR 0.56, 95% CI 0.34-0.94; median not estimable vs 20.3 months). Serious adverse events occurred in 49.3% of EC+FOLFIRI and 44.1% of controls, with safety consistent with known profiles. Investigators conclude EC+FOLFIRI provides a new standard of care for this population.
10.1016/j.annonc.2026.04.017
May 25 – Jun 01, 2026
Post-hoc analysis of adverse events during the EPOCH trial: reconsidering dosimetry.
EUR J NUCL MED MOL I · Q1 JOURNAL - RANK #10/212
This post-hoc analysis of the EPOCH trial examined the impact of yttrium-90 [Y]-radioembolization dosimetry on adverse events in colorectal cancer patients with liver metastases who had progressed following frontline chemotherapy. The study analyzed liver-related treatment-emergent adverse events (TEAEs) and bilirubin increases in 186 patients, reporting TEAEs in 50% of patients, grade 3 or higher TEAEs in 24%, and bilirubin increases in 14%. A theoretical model explored dosimetry parameters, finding that patients with lower fractional tumor involvement (<4.1%) were subjected to higher normal liver absorbed doses (up to 120 Gy). The analysis proposes revised dosimetry guidelines to mitigate TEAEs while maintaining therapeutic efficacy in radioembolization.
10.1007/s00259-026-07948-6
Apatinib enhances anti-PD-1 efficacy by inhibiting Exo70-mediated exosome secretion in pMMR/MSS colorectal cancer.
NPJ PRECIS ONCOL · Q1 JOURNAL - RANK #39/326
This single-arm, exploratory clinical study evaluated the efficacy of camrelizumab combined with apatinib in patients with advanced metastatic pMMR/MSS colorectal cancer who had received third-line or later treatment (NCT04067986). Results showed that apatinib significantly enhanced the therapeutic efficacy of immunotherapy, with mechanistic insights revealing reduced exosomal PD-L1 levels via inhibition of tumor-derived exosome secretion mediated by Exo70. The study provides a theoretical rationale for combining camrelizumab and apatinib in this patient population. No specific numerical efficacy results (e.g., response rates) were reported in the abstract.
10.1038/s41698-026-01518-7
Safety, pharmacokinetics, pharmacodynamics, and antitumor activity of cergutuzumab amunaleukin: a phase I study in patients with advanced and/or metastatic solid tumors.
ESMO OPEN · Q1 JOURNAL - RANK #36/326
This phase I study evaluated the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of cergutuzumab amunaleukin (CA) in 60 patients with advanced/metastatic CEA-positive solid tumors. The study comprised two parts: single-dose (0.1-6 mg, n=5) and multiple ascending doses (10-40 mg q2w, n=31; 6-30 mg qw, n=24), establishing an MTD of 30 mg q2w with dose-limiting toxicities including Gr4 hypophosphatemia and thrombocytopenia. Pharmacokinetics showed dose-proportional exposure (6-40 mg), and pharmacodynamics revealed preferential expansion of CD8+ T and NK cells. No objective responses were observed, but 11% (6/53) achieved stable disease (median duration 4.5 months), supporting further combination therapy development.
10.1016/j.esmoop.2026.107697
Adjuvant chemoradiotherapy versus completion total mesorectal excision after local excision for early rectal cancer (TESAR): a multicentre, randomised, controlled, phase 3, non-inferiority trial.
LANCET GASTROENTEROL · Q1 JOURNAL - RANK #2/147TOP-TIER
This multicentre, open-label, randomised, controlled, phase 3 non-inferiority trial (TESAR) compared adjuvant chemoradiotherapy (25 x 1.8 Gy with capecitabine) to completion total mesorectal excision (cTME) in 202 patients with locally excised high-risk pT1 and low-risk T2 rectal cancer. The primary endpoint was 3-year locoregional recurrence (non-inferiority margin 7%). Estimated 3-year recurrence was 5.0% after chemoradiotherapy vs. 1.1% after cTME, with a non-significant difference (3.9%, 90% CI 0.0-9.4; p=0.16), failing to demonstrate non-inferiority. However, unsalvageable recurrence rates were low (1.3% vs. 0.0%), and 3-year stoma rates were significantly lower after chemoradiotherapy (2.6% vs. 45.4%; p<0.0001), with comparable overall survival. The authors conclude that adjuvant chemoradiotherapy challenges cTME as standard of care due to reduced morbidity and stoma rates, despite not meeting formal non-inferiority for locoregional recurrence.
10.1016/S2468-1253(26)00109-3