Head and Neck Cancers
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Jun 01 – Jun 08, 2026
MAGE-A4/MAGE-A8-targeted TCR-based bispecific T cell engager in recurrent and/or refractory solid tumors: a phase 1 trial.
NAT MED · Q1 JOURNAL - RANK #1/195TOP-TIER
This phase 1 prespecified interim analysis evaluated IMA401, a novel TCR-based bispecific T cell engager, in 61 patients with recurrent and/or refractory solid tumors, administered intravenously with or without pembrolizumab. The primary focus was maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D), with secondary endpoints including safety, antitumor activity, and pharmacokinetics. The MTD was not reached, RP2D was determined as 1-2 mg biweekly, and treatment-related adverse events were primarily grade 1-2 and manageable. Efficacy-evaluable population ORR was 14% (8/56); at RP2D, ORR was 20% (8/41), with the largest subgroup—head and neck cancer—showing 29% (4/14) response and a median response duration of 8.8 months.
10.1038/s41591-026-04455-x
Amivantamab in recurrent/metastatic HNSCC after checkpoint inhibitor and chemotherapy: pivotal results from the phase 1b/2 OrigAMI-4 study.
J CLIN ONCOL · Q1 JOURNAL - RANK #6/326TOP-TIER
This multicenter phase 1b/2 OrigAMI-4 trial prospectively evaluated subcutaneous amivantamab, an EGFR-MET bispecific antibody, in 102 patients with recurrent or metastatic head and neck squamous cell carcinoma who had progressed after PD-(L)1 inhibitor and platinum-based chemotherapy. Participants received amivantamab every three weeks; efficacy was measured by RECIST v1.1 with blinded independent central review, and secondary endpoints included duration of response, progression-free survival, overall survival, and safety. The study achieved a 42 % objective response rate (95 % CI 32–52 %), including 15 % complete responses; median duration of response was not reached, with 56 % ongoing ≥6 months, while median PFS and OS were 6.8 months (95 % CI 5.2–8.3) and 12.5 months (95 % CI 10.2–16.8), respectively. Adverse events were consistent with prior experience, treatment-related discontinuations were 8 %, and investigators conclude amivantamab provides greater antitumor activity than historical paclitaxel or cetuximab in this setting.
10.1200/JCO-26-01042
May 25 – Jun 01, 2026
High-dose stereotactic radiotherapy boost in the radical treatment of head and neck tumors.
RADIAT ONCOL · Q1 JOURNAL - RANK #51/212
This prospective, single-center clinical trial evaluated the efficacy and safety of combining conventionally fractionated radiotherapy with a high-dose stereotactic radiotherapy boost for the radical treatment of head and neck tumors in 28 patients. Tumor response included an 89% complete response rate, with disease progression causing five deaths, and late toxicities such as carotid blow-out syndrome and brain necrosis occurring at higher boost doses. The study found that a boost dose of 10 Gy provided promising efficacy with permissible toxicity compared to higher doses, which increased the risk of adverse events. The study was approved by a bioethics committee and registered on ClinicalTrials.gov, with findings suggesting a potential role for stereotactic boosts in optimizing head and neck cancer outcomes.
10.1186/s13014-026-02857-2
May 18 – May 25, 2026
Near-infrared fluorescence imaging-guided surgery using cRGD-ZW800 to improve surgical resection margins in oral cancer: a phase I/II feasibility trial.
NAT COMMUN · Q1 JOURNAL - RANK #10/135TOP-TIER
This prospective, single-center phase I/II trial (n=31; NCT04191460) evaluated the safety and feasibility of cRGD-ZW800-1, a near-infrared fluorescent integrin-targeted tracer, in improving surgical resection margins for oral squamous cell carcinoma (OSCC). Patients received 0.01, 0.025, or 0.05 mg/kg cRGD-ZW800-1, with tracer uptake quantified using in vivo spectroscopy to optimize dosing and timing. All doses were well tolerated, achieving tumor-to-background ratios >4.5 (optimal at 0.025 mg/kg), and fluorescence imaging detected all 23 inadequate margins (100% sensitivity vs. 70% conventional), altering surgical plans in five cases and avoiding adjuvant radiotherapy in three. The study concludes that cRGD-ZW800-1 is safe, tumor-specific, and enhances intraoperative margin assessment in OSCC.
10.1038/s41467-026-73554-7
Randomized Phase II Trial of Consolidation Pembrolizumab After Definitive Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma: KCSG HN19-09, CONPELAN Study.
HEAD NECK-J SCI SPEC · Q1 JOURNAL - RANK #15/67
In this prospective, randomized phase II trial, patients with stage II-IVB nasopharyngeal carcinoma were allocated 2:1 to receive either consolidation pembrolizumab or placebo following definitive chemoradiotherapy. The main objective was to evaluate 3-year progression-free survival (PFS), with additional analyses of toxicity and immune-related biomarkers. Among 53 participants, the 3-year PFS rates were 56.5% for pembrolizumab and 57.8% for placebo (p=0.142, HR=0.408), and grade ≥3 adverse events occurred in 8.8% of the pembrolizumab arm. Although consolidation pembrolizumab did not significantly improve PFS in unselected patients, exploratory analyses revealed a possible beneficial effect in those with high intratumoral TIL density, suggesting further research is warranted.
10.1002/hed.70329
Cluster Randomized Trial of Intensive Systolic Blood Pressure Control in Patients With Renal Cell or Thyroid Cancer Receiving VEGFR Tyrosine Kinase Inhibitors: ECOG-ACRIN EAQ191.
HYPERTENSION · Q1 JOURNAL - RANK #7/98
This cluster randomized controlled trial assessed the feasibility and safety of intensive systolic blood pressure (SBP) control (<120 mmHg) versus usual care (<140 mmHg) in patients with renal cell or thyroid cancer initiating VEGFR tyrosine kinase inhibitors. A phase II site-based design used 10 sites (5 per arm) enrolling 61 patients (58 renal cell, 3 thyroid), with centralized BP advisory core guidance, home monitoring, and visits at baseline, 1, 2, 3, and 6 months. Mean SBP differences favored intensive control: -12.2 mmHg (95% CI -18.1 to -7.0) at 1 month, -7.6 (95% CI -15.3 to -0.4) at 3 months, and -6.9 (95% CI -19.3 to 6.0) at 6 months; grade 3 adverse events were numerically higher in usual care for kidney injury, hypotension, and dyspnea. The authors conclude this first randomized trial in active cancer patients demonstrates feasibility, safety, and tolerability of intensive SBP control.
10.1161/HYPERTENSIONAHA.125.26016
Pembrolizumab combined with nab-paclitaxel and platinum in recurrent/metastatic HNSCC: efficacy, safety, and survival predictive model.
ESMO OPEN · Q1 JOURNAL - RANK #36/326
This single-arm phase 2 study assessed the efficacy and safety of pembrolizumab combined with nab-paclitaxel and platinum for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). At a 23-month median follow-up (95% CI 19.4-29.6), the objective response rate was 64.2%, disease control rate was 93.2%, progression-free survival was 12.7 months (95% CI 10.2-14.7), and overall survival was 21.8 months (95% CI 18.9-35.7). Hypothyroidism (27%, including one grade 3 case) was the most common immune-related adverse event. A seven-parameter clinical predictive model showed strong prognostic accuracy for stratifying patient risk, with AUCs from 0.753 to 0.919 for progression-free survival and 0.682 to 0.908 for overall survival prediction across training and test datasets.
10.1016/j.esmoop.2026.107733
Comparative study between PET-CT simulation and CT for head and neck cancer treatment and their potential effect on the thyroid gland: a prospective comparative study.
RADIAT ONCOL · Q1 JOURNAL - RANK #51/212
This prospective comparative analysis evaluated whether PET-CT simulation offers advantages over CT-alone planning in head and neck cancer (HNC) radiotherapy. Two patient groups (PET-CT versus CT) received radiotherapy, and blood samples were collected pre- and post-treatment to measure TSH, FT3, and FT4. Results showed a 71.8% improvement in GTVp delineation accuracy with PET-CT, accompanied by minor TSH declines but significant drops in FT3 and FT4, mainly in stage II/III patients. Researchers concluded that PET-CT integration enhances RT planning while underscoring the necessity for diligent thyroid function monitoring in HNC treatment.
10.1186/s13014-026-02840-x
Long-Term Outcomes of Reduced-Dose Radiotherapy in Patients with Epstein-Barr Virus DNA-Selected Stage III Nasopharyngeal Carcinoma: A 5-Year Follow-Up Secondary Analysis of a Phase II Trial.
INT J RADIAT ONCOL · Q1 JOURNAL - RANK #14/212
This secondary analysis of a single-arm phase II trial evaluated long-term outcomes of reduced-dose radiotherapy in low-risk stage III nasopharyngeal carcinoma (NPC) sensitive to induction chemotherapy (IC). All 215 patients received two cycles of IC; 116 with complete/partial response and undetectable EBV DNA received 60 Gy intensity-modulated radiotherapy (IMRT), while 99 received standard 70 Gy. At 68.1 months median follow-up, 5-year progression-free survival was 90.5% (60 Gy) vs. 79.8% (70 Gy), and overall survival was 96.6% vs. 94.9%; no grade 3-4 late toxicity occurred in the 60 Gy group versus 10.1% in the 70 Gy group. The authors conclude that reduced-dose IMRT achieves favorable survival with limited late toxicities in this selected population.
10.1016/j.ijrobp.2026.05.008
May 11 – May 18, 2026
Phase I trial of CJRB-101 plus pembrolizumab in patients with metastatic non-small cell lung cancer, head and neck squamous cell carcinoma and melanoma.
J IMMUNOTHER CANCER · Q1 JOURNAL - RANK #12/183TOP-TIER
This first-in-human, two-part, phase I trial evaluated CJRB-101 (1×10 or 4×10 CFU/day) plus pembrolizumab (200 mg Q3W) in 42 patients with advanced NSCLC, melanoma, or HNSCC in ICI-naïve and ICI-refractory settings. In preclinical PDX models, CJRB-101 plus pembrolizumab showed enhanced tumor growth inhibition (TGI) of 61.9% versus 77.3% with CJRB-101 alone, alongside M2-to-M1 repolarization and cytotoxic T-cell activation. None of the patients experienced dose-limiting toxicities, and in ICI-naïve NSCLC with PD-L1 >50% (n=12), the overall response rate reached 58%, disease control was 75%, and the median progression-free survival was 9 months. The combination was well-tolerated, including in ICI-refractory cases with ORR of 5% and DCR of 41%, supporting further investigation of CJRB-101 plus pembrolizumab in advanced solid tumors.
10.1136/jitc-2025-014702
Estimation of accumulated dose to organs at risk in head and neck cancer patients treated with scheduled replanning and dose painting in the ARTFORCE trial.
PHYS IMAG RADIAT ONC · Q1 JOURNAL - RANK #46/212
This prospective study examined whether scheduled adaptive radiotherapy with dose painting (DP) could improve delivered dose to organs at risk (OARs) in 81 patients with locally advanced head and neck cancer. The investigators used deformable image registration between CBCT and planning CTs to estimate delivered doses under three simulated conditions: no replanning, single intervention at fraction 12, and ad hoc clinical practice. They found that without ART, 41% of patients had delivered dose deviations ≥3 Gy in OARs, with minimal improvements from ad hoc replanning, though using accumulated dose in the first ten fractions (Df10) to select patients for ART improved larynx dose significantly (P ≤ 0.01). The authors conclude that Df10 is prognostic for relevant changes from planned to delivered doses and that patient-targeted ART implementation could enhance larynx dose outcomes.
10.1016/j.phro.2026.100957
Efficacy of buparlisib according to PIK3CA mutation status in recurrent or metastatic head and neck squamous cell carcinoma: A multicenter phase II trial.
ORAL ONCOL · Q1 JOURNAL - RANK #18/162
This multicenter phase II trial aimed to evaluate buparlisib in patients with recurrent or metastatic HNSCC after progression on platinum and cetuximab therapy, focusing on outcomes by PIK3CA mutation status. Patients in two parallel cohorts (PIK3CA-mutated and wild-type) received buparlisib 100 mg/day, with the primary endpoint as 2-month Disease Control Rate (DCR2m). Among 58 enrolled patients, DCR2m was 38.9% (95% CI: 25.5 to +∞) for the wild-type cohort and 36.4% (95% CI: 19.5 to +∞) for the PIK3CA-mutated group, and 53.4% experienced grade ≥3 adverse events. Despite meeting the primary endpoint, the study concluded that buparlisib monotherapy had limited efficacy and unacceptable toxicity in heavily pretreated HNSCC.
10.1016/j.oraloncology.2026.108004
A Phase II study of SHR-A1921, a TROP2-targeted antibody-drug conjugate, in patients with recurrent or metastatic salivary gland carcinoma.
NPJ PRECIS ONCOL · Q1 JOURNAL - RANK #39/326
This phase II single-center clinical trial assessed SHR-A1921, a TROP-2-targeted antibody-drug conjugate, in 17 patients with recurrent or metastatic HER2-negative/AR-negative salivary gland carcinoma, administered every three weeks until progression or unacceptable toxicity. The methodology included efficacy evaluation per RECIST v1.1 and exploratory analyses of baseline TROP-2 expression. For non-adenoid cystic carcinoma patients, the objective response rate was 20.0%, disease control rate 80.0%, and clinical benefit rate 60.0%, while all adenoid cystic carcinoma patients achieved stable disease with a median progression-free survival of 15.4 months. SHR-A1921 demonstrated manageable safety, preliminary efficacy, and disease stabilization, supporting further study in stratified cohorts.
10.1038/s41698-026-01463-5
Acute and long-term toxicity profiles and final oncologic outcomes in the phase III ARTFORCE trial.
RADIOTHER ONCOL · Q1 JOURNAL - RANK #22/212
This study reports acute and five-year toxicity and oncologic outcomes from the phase III ARTFORCE trial, a multicenter randomized trial evaluating FDG-PET-guided adaptive dose-redistributed radiotherapy (rRT) versus conventional radiotherapy (cRT) in 221 patients with locally advanced head and neck squamous cell carcinoma. Patients received 64-84 Gy (rRT) or 70 Gy (cRT) in 35 fractions with concurrent cisplatin. Acute toxicity rates were similar between arms (P ≥ 0.10); five-year locoregional control showed HR 0.78 (95% CI 0.45-1.36; P=0.39). Late toxicity was consistent with two-year results except higher Grade≥3 pharyngolaryngeal stenosis in rRT (0% vs 4%, P=0.05). The authors conclude that rRT yields similar acute and long-term toxicity, tumor control, and survival as cRT, supporting long-term safety.
10.1016/j.radonc.2026.111572
Randomized non-comparative phase II trial of nivolumab plus paclitaxel in subjects with recurrent/metastatic head and neck squamous cell carcinoma unable for cisplatin-based chemotherapy. NIVOTAX TTCC study.
EUR J CANCER · Q1 JOURNAL - RANK #45/326
The NIVOTAX trial was a randomized, non-comparative, multicenter phase II study evaluating paclitaxel plus nivolumab (nivotax) versus cetuximab in platinum-ineligible recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) patients. The study randomized 141 patients (93 to nivotax, 48 to cetuximab) and assessed 2-year overall survival (2yOS) as the primary endpoint, with secondary endpoints including median OS, PFS, ORR, and safety. Results showed a 2yOS of 24.7% (95% CI 15.9-33.5) for nivotax and 13.4% (95% CI 3.6-23.2) for cetuximab, with similar median OS, PFS, and ORR between arms, but higher respiratory adverse events (38% grade ≥3) and mortality (18%) in the nivotax arm. The study concluded that while the primary endpoint was met, respiratory toxicity and associated mortality in the nivotax arm limit its further evaluation.
10.1016/j.ejca.2026.116775
May 04 – May 11, 2026
Ficerafusp Alfa (BCA101) With Pembrolizumab for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Two-Year Results of an Expansion Cohort of a Phase I/Ib Trial.
J CLIN ONCOL · Q1 JOURNAL - RANK #6/326TOP-TIER
This phase I/Ib expansion cohort trial evaluated ficerafusp alfa plus pembrolizumab as first-line treatment for PD-L1-positive recurrent/metastatic head and neck squamous cell carcinoma. Forty-two patients received treatment, with 39 evaluable for efficacy; median follow-up was 26.3 months. Grade 3 treatment-related adverse events occurred in 45% of patients; in HPV-negative patients (n=28), confirmed objective response rate was 54% (21% complete response), median duration of response 21.7 months, median progression-free survival 9.9 months, and median overall survival 21.3 months. The combination demonstrated favorable safety and promising activity, particularly in HPV-negative disease.
10.1200/JCO-25-02027
Risk-adapted therapy guided by human papillomavirus (HPV) circulating tumor DNA in HPV-positive oropharyngeal cancer (ReACT 1.0): an exploratory phase II trial.
NAT COMMUN · Q1 JOURNAL - RANK #10/135TOP-TIER
This phase 2 exploratory clinical trial tested risk-adapted de-intensified (chemo)radiation guided by on-treatment HPV circulating tumor DNA (ctDNA) in HPV-positive oropharyngeal carcinoma, enrolling 102 patients. Intermediate-risk patients (T4 or >10 pack-years with baseline HPV ctDNA >200) were reclassified as low-risk if mid-treatment HPV ctDNA declined >95%, and all clinically low-risk or reclassified patients received de-escalation. Among 89 de-escalated patients (60 low-risk, 29 reclassified), 2-year progression-free survival was 93% (95% CI, 87–99); secondary outcomes included tolerability, distant metastatic-free, and overall survival (not numerically specified). Post-hoc analyses indicated distinct ctDNA kinetics and favorable outcomes for reclassified intermediate-risk patients, supporting HPV ctDNA as a biomarker to refine risk stratification and enable safe de-escalation (NCT04900623).
10.1038/s41467-026-72984-7
Penpulimab and Gemcitabine With or Without Anlotinib in Metastatic Nasopharyngeal Carcinoma: A Randomized, Open-Label, Multicenter Phase 2 Study.
INT J CANCER · Q1 JOURNAL - RANK #77/326
This prospective, randomized, open-label, multicenter phase 2 study evaluated anlotinib as a cisplatin substitute in gemcitabine-penpulimab combinations for metastatic nasopharyngeal carcinoma (NPC) patients previously treated with cisplatin. The lead-in phase randomized 20 patients 1:1:1 to GP-PA (n=8), GP-P (n=6), or GAP (n=6); the expansion phase added 14 patients to the optimal GAP arm. Primary endpoints were safety and objective response rate (ORR); ORR/DCR were 62.5%/87.5% (GP-PA), 83.3%/100% (GP-P), and 100%/100% (GAP); in the expansion phase, GAP showed 93.3% ORR with 71.4% grade ≥3 TEAEs. The GAP regimen demonstrated favorable safety and efficacy, suggesting anlotinib may replace cisplatin in this population.
10.1002/ijc.70542
Enfortumab vedotin plus pembrolizumab as first-line treatment in recurrent or metastatic head and neck squamous cell carcinoma: results from EV-202 cohort 9.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This phase 2, open-label multicohort clinical trial assessed safety and efficacy of enfortumab vedotin (EV) combined with pembrolizumab as first-line therapy in 41 patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) and PD-L1 CPS ≥1. Participants received EV (1.25 mg/kg IV) on days 1 and 8, and pembrolizumab (200 mg IV) on day 1 in 21-day cycles, with endpoints including objective response rate (cORR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety. The confirmed objective response rate was 39.0% (95% CI: 24.2–55.5), complete response rate 9.8%, and estimated 6-month DOR rate 81.7% (95% CI: 42.0–95.4); median PFS was 5.1 months (95% CI: 3.5–NE). EV plus pembrolizumab showed promising clinical activity and manageable safety profile in this population.
10.1158/1078-0432.CCR-25-4650
Apr 20 – Apr 27, 2026
Fianlimab, a human lymphocyte activation gene-3 monoclonal antibody, in combination with cemiplimab: Tumor-specific expansion cohorts in advanced malignancies.
CANCER-AM CANCER SOC · Q1 JOURNAL - RANK #68/326
This phase 1 dose-expansion study evaluated fianlimab (anti-LAG-3) plus cemiplimab (anti-PD-1) in patients with advanced NSCLC, ccRCC, HNSCC, and CSCC. Patients received 1600 mg fianlimab plus 350 mg cemiplimab every 3 weeks for up to 24 months, with ORR per RECIST 1.1 as the primary endpoint. Investigator-assessed ORR was 27% in NSCLC-N, 7% in NSCLC-E, 20% in ccRCC-N, 7% in ccRCC-E, 33% in HNSCC-N, 7% in HNSCC-E, and 20% in CSCC-E. The combination demonstrated modest efficacy with acceptable safety, warranting further investigation.
10.1002/cncr.70396
Safety and Efficacy of Lucitanib Plus Toripalimab in Advanced Solid Tumors Refractory to Standard Therapies: An Open-Label, Multicenter, Phase II Study.
MEDCOMM · Q1 JOURNAL - RANK #14/195TOP-TIER
This open-label, multicenter, single-arm Phase II study examined lucitanib combined with toripalimab in 131 patients with advanced solid tumors refractory to standard therapies. Patients were categorized into four cohorts based on tumor type, and the primary outcome, objective response rate (ORR), ranged from 13.5% to 45.8% across cohorts. Secondary outcomes included progression-free survival (PFS), which was highest in the NPC (PD-1-naïve) cohort with a median of 6.5 months (95% CI, 4.0-NE). The treatment demonstrated promising antitumor activity with manageable toxicity, including hypertension (37.4%), proteinuria (10.7%), and thrombocytopenia (10.7%), warranting further randomized investigations in specific tumor subtypes like NPC and EC.
10.1002/mco2.70672
Risk factors for aspiration pneumonia related to postoperative chemoradiotherapy for high-risk head and neck cancer: A supplementary analysis of a phase II/III JCOG1008 trial.
ORAL ONCOL · Q1 JOURNAL - RANK #18/162
This supplementary analysis of the randomized phase II/III JCOG1008 trial investigated clinical risk factors for aspiration pneumonia (AP) following postoperative chemoradiotherapy (POCRT) in patients with resected high-risk head and neck cancer. The study excluded laryngectomy patients and analyzed 151 participants receiving POCRT, using logistic regression to assess AP incidences and identify risk factors. Multivariable analysis found that dysphagia ≥ grade 3 during CRT (OR 4.691, p = 0.0009) and reconstruction surgery (OR 2.859, p = 0.0061) independently increased AP risk, with AP affecting 74.8% overall. AP occurrence was not significantly associated with overall, relapse-free, or local relapse-free survival, highlighting vigilance for high-risk patients.
10.1016/j.oraloncology.2026.107977
Apr 13 – Apr 20, 2026
Long-Term Results of a Phase II Clinical Trial of Radiation Volume and Dose De-intensification Following Transoral Robotic Surgery and Neck Dissection for Human Papillomavirus-Associated Oropharyngeal Squamous Cell Carcinoma.
INT J RADIAT ONCOL · Q1 JOURNAL - RANK #14/212
This Phase II prospective clinical trial evaluated whether reducing both the volume and dose of adjuvant radiation therapy after transoral robotic surgery (TORS) and neck dissection could maintain tumor control in patients with pT0-T3 pN0-N1 HPV-associated oropharyngeal squamous cell carcinoma. One hundred forty-nine patients received 25 fractions over five weeks, with omission of the primary resection bed in low-risk cases, reduction of contralateral neck targets, and doses of 50 Gy to high-risk and 45 Gy to lower-risk regions; concurrent chemotherapy was given only for positive margins or extranodal extension. After a median 48-month follow-up, no local failures and two regional recurrences occurred, yielding a 5-year locoregional control rate of 98.0 % (95 % CI 95.3–100); distant metastases developed in 6.7 % and disease-specific mortality was 2.0 %. The authors conclude that this de-intensified adjuvant RT strategy preserves excellent locoregional control with low toxicity, and detectable postoperative HPV ctDNA predicted later metastasis but not locoregional failure.
10.1016/j.ijrobp.2026.04.015
Clinical Value of Patient-Derived Tumor Organoids in Guiding Precision Chemotherapy for Locally Advanced Thyroid Cancer: A Single-Center, Single-Arm, Phase 2 Trial.
INT J CANCER · Q1 JOURNAL - RANK #77/326
The primary objective was to use patient-derived tumor organoids to guide precision chemotherapy for locally advanced thyroid cancer. In this prospective, single-center, single-arm Phase 2 trial, 25 patients were enrolled, and organoid-based drug sensitivity testing determined individualized chemotherapy regimens. Key results included a 53.3% overall response rate (ORR) in the 15 treated patients (ORR of anaplastic thyroid carcinoma patients at 87.5%), a median tumor reduction of 40.32% (IQR: 7.89%-65.22%), and 80% surpassing six months of progression-free survival. These findings show that organoid-based strategies can guide personalized chemotherapy in locally advanced thyroid carcinoma, potentially improving outcomes.
10.1002/ijc.70504
Axitinib plus Avelumab in Recurrent/Metastatic Adenoid Cystic Carcinoma: Biomarker Analysis and Updated Results of the Phase II Trial.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This Phase II clinical trial evaluated the combination of axitinib and avelumab in 28 patients with recurrent/metastatic adenoid cystic carcinoma (ACC), with the primary objective of assessing biomarkers predictive of clinical benefit. The study incorporated pre-treatment tumor analysis, including whole exome sequencing, transcriptome profiling, imaging mass cytometry, microbiome characterization, and subtype classification (ACC-I vs. ACC-II). Results showed subtype-specific progression-free survival (PFS), with a median of 1.8 months for ACC-I versus 11.4 months for ACC-II (HR, 0.14; P<0.0001), and identified a 167-gene immune-enriched signature that predicted benefit from immunotherapy-based combinations but not from regorafenib monotherapy. The study concluded that clinical benefit depends on ACC subtype, and the identified signature could inform future biomarker-driven clinical trial designs and patient stratification strategies.
10.1158/1078-0432.CCR-25-4599
Effects of rhuGM-CSF on prevention and treatment of oral mucositis in patients receiving radiotherapy for head and neck cancer: A randomized controlled trial.
RADIOTHER ONCOL · Q1 JOURNAL - RANK #22/212
This randomized controlled trial aimed to evaluate the efficacy of prophylactic rhuGM-CSF mouthwash in preventing severe oral mucositis (SOM) and to explore related immune biomarkers in 100 patients with head and neck cancer undergoing radiotherapy. Patients were assigned to either prophylactic (n = 50, starting rhuGM-CSF at initiation) or treatment (n = 50, starting after grade 1 OM) groups, with primary and secondary endpoints assessing SOM incidence, duration, onset, and quality of life. Results showed that SOM incidence was significantly lower in the prophylactic group (33.3% vs 66.7%; HR = 0.31, 95% CI 0.17-0.57, p < 0.001), and median SOM duration was reduced (0 vs 14 days, p < 0.001); exploratory analysis revealed a potential protective role for baseline activated CD4+CD38+/CD4+ T cell percentage. The study concluded that prophylactic rhuGM-CSF mouthwash effectively decreases SOM occurrence and duration, while baseline immune biomarker levels may predict risk.
10.1016/j.radonc.2026.111527
Apr 06 – Apr 13, 2026
Durvalumab combined with weekly carboplatin/paclitaxel as first-line treatment of patients with recurrent and/or metastatic HNSCC not eligible for cisplatin-based chemotherapies: results of the multicenter prospective study FRAIL-IMMUNE.
ESMO OPEN · Q1 JOURNAL - RANK #36/326
The study evaluated the efficacy and tolerance of durvalumab combined with weekly carboplatin/paclitaxel as first-line treatment for recurrent and/or metastatic head and neck squamous-cell carcinoma (HNSCC) in patients ineligible for cisplatin-based chemotherapy. This prospective multicenter single-arm phase II trial included 64 patients with ECOG-PS 0-1 (cohort A) and 39 assessable patients with ECOG-PS 2 (cohort B), treated with four 28-day chemotherapy cycles plus durvalumab for up to 12 months. The primary endpoint was met, with 62.5% (95% CI 51.5%-∞) of cohort A and 51.3% (95% CI 37.1%-∞) of cohort B alive at 12 months. The results support further investigation of this regimen in a phase III trial for frail R/M HNSCC patients.
10.1016/j.esmoop.2026.106946
Phase 1b study of ABBV-368, tilsotolimod, budigalimab, and nab-paclitaxel in patients with recurrent/metastatic head and neck squamous cell carcinoma.
J IMMUNOTHER CANCER · Q1 JOURNAL - RANK #12/183TOP-TIER
This Phase 1b, multicenter, open-label clinical trial investigated the safety, tolerability, pharmacokinetics, and preliminary antitumor efficacy of ABBV-368, a monoclonal antibody targeting OX40, in combination with tilsotolimod, budigalimab, and nab-paclitaxel in adult patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). Patients (n=30) were enrolled into three treatment arms and treated in 28-day cycles with a combination of intravenous and intratumoral interventions. Notable results include an overall response rate of 14.3% from two patients exhibiting partial responses, while 80% experienced any-grade adverse events; limited clinical responses were attributed to resistance mechanisms and an unfavorable tumor microenvironment. The study concluded that the quadruple combination was well tolerated but insufficient at overcoming therapy resistance, necessitating future work to optimize immunotherapy schedules and address inhibitory environments.
10.1136/jitc-2025-014086
TNFRSF1A (-135 T>C, rs767455) Polymorphism as a Predictor of Radiation Induced Oral Mucositis and Treatment Response in Locally Advanced Head and Neck Cancer Patients.
HEAD NECK-J SCI SPEC · Q1 JOURNAL - RANK #15/67
This study investigated the role of the TNFRSF1A (-135 T>C, rs767455) polymorphism as a predictor of radiation-induced oral mucositis and treatment response in 50 patients with locally advanced head and neck squamous cell carcinoma (HNSCC) undergoing intensity-modulated radiation therapy (IMRT) with weekly cisplatin. Pre-treatment blood samples were analyzed for genotyping and TNF-α levels, while treatment toxicity and response were assessed using standard grading scales and a predictive Random Forest model. Key findings include a higher risk of severe mucositis among carriers of the C allele (OR = 4.58, p = 0.010) and a correlation between the TT genotype, complete response (OR = 7.00, p = 0.002), and higher serum TNF-α levels (p = 0.041). The study concluded that TNFRSF1A polymorphism is a potential biomarker for personalizing radiotherapy in HNSCC, but larger cohort validation is needed.
10.1002/hed.70277
Anti-PD-1 antibody penpulimab plus chemotherapy for recurrent or metastatic nasopharyngeal carcinoma: a randomized, double-blind phase 3 study.
SIGNAL TRANSDUCT TAR · Q1 JOURNAL - RANK #1/319TOP-TIER
This randomized, double-blind phase 3 study evaluated the efficacy and safety of anti-PD-1 antibody penpulimab plus chemotherapy versus placebo plus chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma. The trial randomized 291 patients in a 1:1 ratio to receive either penpulimab (n=144) or placebo (n=147) combined with cisplatin/carboplatin and gemcitabine every 3 weeks, followed by maintenance therapy. The primary endpoint of progression-free survival showed significantly longer median PFS in the penpulimab arm (9.63 months) versus placebo (7.00 months) with a hazard ratio of 0.45 (95% CI: 0.33-0.62, P<0.0001), while overall survival data remained immature. The study concluded that adding penpulimab to chemotherapy significantly improved PFS with a manageable safety profile, with grade ≥3 treatment-related adverse events occurring in 89.0% and 85.9% of patients in the two arms.
10.1038/s41392-026-02645-0
Preoperative Chemoimmunotherapy followed by salvage surgery and adjuvant tislelizumab for previously irradiated R HNSCC: A prospective, phase II trial.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This prospective phase II single-arm trial enrolled 34 patients with previously irradiated, resectable recurrent HNSCC and tested two 3‑weekly cycles of preoperative tislelizumab (200 mg) plus albumin-bound paclitaxel (260 mg/m²) and cisplatin (60–75 mg/m²), followed by salvage surgery and six adjuvant tislelizumab cycles. The primary endpoint was major pathological response (MPR), with secondary endpoints including pCR, objective response rate (ORR), 2‑year event‑free survival (EFS), overall survival (OS), and safety; ORR was 35.3% (12/34), R0 resection was achieved in 73.1% (19/26) of surgical patients, MPR was 19.2% (5/26), and pCR was 15.4% (4/26). At a median follow‑up of 32 months, 2‑year EFS and OS were 39.6% and 54.8%, respectively, and all MPR patients remained disease‑free, with predominantly grade 1–2 adverse events and one grade 3 hyperglycemia. Exploratory analyses showed that higher baseline B‑cell receptor repertoire diversity and clonal abundance (top 1%/10%) correlated with poorer prognosis, with top 1% clonality demonstrating strong prognostic power (AUC=0.910, p=0.006), supporting the feasibility of this chemoimmunotherapy‑surgery approach with encouraging survival.
10.1158/1078-0432.CCR-25-4693
Mar 30 – Apr 06, 2026
Durvalumab plus tremelimumab for the treatment of patients with progressive, refractory advanced thyroid carcinoma: the phase II GETNE-DUTHY trial.
NAT COMMUN · Q1 JOURNAL - RANK #10/135TOP-TIER
The primary objective was to determine whether dual anti-PD-L1/CTLA-4 inhibition with durvalumab and tremelimumab improves clinical outcomes in advanced thyroid cancer, using a phase II, single-arm, multi-cohort prospective clinical trial design. Patients with differentiated, medullary, and anaplastic thyroid carcinoma were recruited into three cohorts and treated with active immunotherapy; endpoints included progression-free and overall survival as well as objective response rates and safety. Key findings showed 6-month progression-free survival rates of 32.4% (Cohort 1) and 40.8% (Cohort 2), 6-month overall survival of 65.6% (Cohort 3), and objective response rates of 8%, 10%, and 33% for the three cohorts respectively. The treatment met the primary endpoint in anaplastic thyroid carcinoma and showed no new safety signals.
10.1038/s41467-026-71155-y
Preventive effects of dexamethasone oral solution on radiation-induced mucositis in patients with head and neck cancer: a randomized, triple-blind, parallel-group trial.
SUPPORT CARE CANCER · Q1 JOURNAL - RANK #17/173
This randomized, triple-blind, parallel-group trial aimed to evaluate the prophylactic efficacy of a dexamethasone oral solution in reducing radiation-induced oral mucositis among 54 patients with non-metastatic head and neck squamous cell carcinoma undergoing ≥60 Gy radiotherapy. Patients were randomized 1:1 to the dexamethasone or placebo groups and assessed for mucositis severity, pain levels, dysphagia, and treatment discontinuation. The dexamethasone group exhibited significantly reduced mucositis severity (all p < 0.01), delayed peak severity (week 5 vs. week 3), lower pain scores (median VAS 0-3 vs 4-6, p < 0.01), and reduced dysphagia at 2 months (32% vs 72%; p = 0.01), without adverse treatment-related systemic effects. These promising findings from this phase II trial require confirmation in larger trials with longer follow-ups and additional outcomes for broader clinical relevance.
10.1007/s00520-026-10603-3