✦ Cancer Clinical Trials

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Head and Neck Cancers

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Oct 12 – Oct 19, 2026

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

Oct 05 – Oct 12, 2026

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

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

Sep 28 – Oct 05, 2026

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

Sep 21 – Sep 28, 2026

STOP Lower Cranial Neuropathy: High-Dose Corticosteroid Therapy for Late Radiation-Associated Lower Cranial Neuropathy in Oropharyngeal Cancer Survivors: Interim Analysis of a Phase I Dose-Finding Trial.
▼INT J RADIAT ONCOL · Q1 JOURNAL - RANK #14/212
This interim analysis of the STOP LCNP phase I/II dose-finding trial prospectively evaluated high-dose corticosteroid therapy in oropharyngeal cancer survivors with radiation-associated lower cranial neuropathy. Eligible participants were disease-free, ≥2 years post-radiation, with electromyography-confirmed LCNP, randomized to oral prednisone at 1 mg/kg (n=3) or 3 mg/kg (n=5) daily for 5 days with a 2-week taper. All regimens were feasible and well tolerated with insomnia as the most frequent adverse event; the 3 mg/kg group showed a median symptom score change of -1.6 versus -0.2 at 1 mg/kg, with 3 of 5 patients achieving clinically meaningful short-term improvement that was not durable at 6-10 weeks. The authors concluded that high-dose corticosteroids were feasible and tolerable in long-term HNC survivors, though objective functional and electrophysiologic measures showed no consistent improvement at either dose level.
10.1016/j.ijrobp.2026.08.056

Toripalimab Plus TPF as Induction Chemoimmunotherapy for the Treatment of Locally Advanced Hypopharyngeal Carcinoma: A Prospective Phase II Study.
▼HEAD NECK-J SCI SPEC · Q1 JOURNAL - RANK #15/67
This single-arm phase II trial evaluated toripalimab plus TPF as induction chemoimmunotherapy in 29 patients with locally advanced hypopharyngeal squamous cell carcinoma, with the primary endpoint being CR rate at 3 months after definitive local treatment. Among 29 enrolled patients (62.1% N3b), the CR rate was 86.2% (25/29), with 80.0% (16/20) among non-surgical patients and 100% (9/9) among surgical patients maintaining disease-free status. The laryngeal-preservation rate was 86.2%, with an overall response rate of 81.5%, and at a median follow-up of 38.3 months, 3-year progression-free survival, overall survival, and larynx preservation survival were 64.0%, 76.3%, and 68.8%, respectively. The authors concluded that toripalimab combined with TPF showed encouraging efficacy, promising larynx preservation, and acceptable toxicity in this LA HSCC cohort.
10.1002/hed.70417

Sep 14 – Sep 21, 2026

PDS0101 With Pembrolizumab in HPV16-Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: A Phase 2 Nonrandomized Clinical Trial.
▼JAMA ONCOL · Q1 JOURNAL - RANK #14/326TOP-TIER
VERSATILE-002 was a phase 2, open-label, multicenter, nonrandomized clinical trial evaluating PDS0101 plus pembrolizumab in 88 participants with HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma across the US, UK, and Ireland. The study used a Simon 2-stage optimal design with separate ICI-naive and ICI-resistant cohorts; efficacy was assessed in 75 mITT patients and safety in 87 treated patients. Among 53 ICI-naive participants, the objective response rate was 34.0%, median progression-free survival was 5.3 months, and median overall survival was 39.3 months, while no objective responses occurred among 22 ICI-resistant patients despite a median overall survival of 14.8 months. Grade 3 or higher treatment-related adverse events occurred in 13.8%, and the authors concluded that PDS0101 plus pembrolizumab showed antitumor activity in ICI-naive HPV16-positive R/M HNSCC, supporting further evaluation in the first-line setting.
10.1001/jamaoncol.2026.3492

Amivantamab plus pembrolizumab in previously untreated recurrent/metastatic head and neck squamous cell cancer: Results from the phase 1b/2 OrigAMI-4 study.
▼CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This phase 1b/2 trial (OrigAMI-4, Cohort 2) evaluated first-line subcutaneous amivantamab plus intravenous pembrolizumab in 39 patients with previously untreated recurrent/metastatic head and neck squamous cell carcinoma and PD-L1 CPS ≥1. Treatment was administered every 3 weeks, with investigator-assessed ORR as the primary endpoint. Confirmed ORR was 59% (95% CI 42-74), including 7 (18%) complete responses; median DoR was not reached, CBR was 74%, median PFS was 7.7 months, and median OS was not reached. The combination demonstrated meaningful antitumor activity with a safety profile consistent with prior reports, suggesting a promising new option for this population.
10.1158/1078-0432.CCR-26-1372

A viral-based individualized neoantigen vaccine as adjuvant treatment in resected head and neck squamous cell carcinoma: a randomized Phase I trial.
▼NAT COMMUN · Q1 JOURNAL - RANK #10/135TOP-TIER
This randomized Phase I trial evaluated TG4050, an individualized neoantigen vaccine delivered by Modified Vaccinia Ankara, as adjuvant treatment in resected head and neck squamous cell carcinoma. Patients were randomized to immediate vaccination after standard adjuvant therapy versus watchful waiting with vaccination upon recurrence, with safety as the primary endpoint and feasibility, efficacy, and immunogenicity as secondary or exploratory endpoints. Among 16 evaluable patients in the immediate arm, none relapsed at a median follow-up of 30 months, compared to 3 of 16 relapses in the control arm; vaccine-specific T cell responses occurred in 73.3% of treated patients, targeting a median of 3 neoantigens. The authors conclude that TG4050 induces durable neoantigen-specific cytotoxic T cell responses that may prevent recurrence, supporting further investigation.
10.1038/s41467-026-76667-1

Sep 07 – Sep 14, 2026

OPEN: optimising patient experience in head and neck radiotherapy, a phase 3 randomised control trial comparing open versus closed face masks.
▼RADIOTHER ONCOL · Q1 JOURNAL - RANK #22/212
This phase 3 randomized controlled trial aimed to compare open face masks with surface guided radiotherapy (SGRT) versus standard closed masks for head and neck radiotherapy immobilization, assessing setup accuracy and patient experience. Two hundred thirty non-claustrophobic patients receiving radical radiotherapy were randomized 1:1:1 to closed 5-point masks without SGRT, 3-point open masks with SGRT, or 5-point open masks with SGRT, with setup accuracy evaluated via daily CBCT and SGRT. Significant differences in inter-fraction motion were observed only in the longitudinal axis, where closed-mask patients had larger shifts compared to both open-mask arms (P<0.001), with no other significant variations in vertical, lateral, or rotational axes. Patient experience metrics including tolerability, overall experience, and distress were significantly more favorable for both open-mask cohorts compared to closed masks (p<0.01), supporting the adoption of open-mask SGRT-based immobilization as a patient-centered solution with equivalent setup accuracy.
10.1016/j.radonc.2026.111779

Neoadjuvant chemoimmunotherapy with afatinib for locally advanced head and neck squamous cell carcinoma (neoCHANCE-2): an open-label, single-arm, phase 2 study.
▼J IMMUNOTHER CANCER · Q1 JOURNAL - RANK #12/183TOP-TIER
This open-label, single-arm, phase 2 trial evaluated neoadjuvant tislelizumab plus nab-paclitaxel/cisplatin chemotherapy with afatinib in 40 patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC). Among 32 patients who underwent surgical resection, the primary endpoint of pCR was 40.6% (95% CI 23.7-59.4%), with ORR of 82.5% and 1-year OS of 97.3%. Grade 3-4 lymphopenia occurred in 12.5% of patients, with no grade 5 TRAEs or surgical delays. The authors conclude that this neoadjuvant chemoimmunotherapy regimen shows promising efficacy and acceptable safety, warranting further large-scale evaluation.
10.1136/jitc-2025-014100

Efficacy and safety of liposomal irinotecan plus nimotuzumab in immune checkpoint inhibitor-refractory recurrent or metastatic nasopharyngeal carcinoma: a single-arm, open-label, phase II trial.
▼ECLINICALMEDICINE · Q1 JOURNAL - RANK #11/332
This single-arm, open-label, phase II trial evaluated liposomal irinotecan plus nimotuzumab in 36 patients with EGFR-positive, immune checkpoint inhibitor-refractory recurrent or metastatic nasopharyngeal carcinoma. Patients received intravenous liposomal irinotecan (70 mg/m²) plus nimotuzumab (400 mg) every two weeks for up to eight cycles, with the primary endpoint being objective response rate per RECIST v1.1. The intention-to-treat ORR was 36.1% (13/36; 95% CI 20.8-53.8), disease control rate was 61.1%, median progression-free survival was 3.0 months, median duration of response was 2.3 months, and median overall survival was 14.1 months; grade ≥3 treatment-related adverse events occurred in 22.2% with no treatment-related deaths. The authors concluded that this combination showed preliminary antitumor activity and manageable safety in heavily pretreated patients, though response durability was limited and further comparative studies are needed.
10.1016/j.eclinm.2026.104170

Response-Adapted Surgery after Neoadjuvant Immunochemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma (REMATCH): A Single-Arm Phase II Trial.
▼CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This single-arm phase II prospective trial evaluated response-adapted surgery after neoadjuvant immunochemotherapy in 50 patients with resectable HPV-negative stage III-IVA head and neck squamous cell carcinoma. All patients received three cycles of penpulimab, nab-paclitaxel, and cisplatin, followed by reduced-volume surgery if ≥50% tumor regression or standard-volume surgery otherwise, plus risk-adapted adjuvant radiotherapy. The 2-year disease-free survival was 83% overall, with 90% in the reduced-volume group and 20% in the standard-volume group; grade 3 adverse events occurred in 16% during immunochemotherapy and 15% after surgery. The authors conclude that response-adapted surgery is feasible and warrants phase III validation.
10.1158/1078-0432.CCR-26-1337

A phase II trial of chemotherapy-free neoadjuvant camrelizumab plus apatinib for resectable HNSCC: pathological response and vascular-immune crosstalk.
▼CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This single-arm phase II trial evaluated neoadjuvant camrelizumab plus apatinib in 41 patients with resectable HNSCC, randomly assigning them 2:1 to one or two cycles. The primary endpoints were safety and major pathological response (MPR); the overall MPR rate was 29.3% (40.0% vs 23.1% for two vs one cycle, p=0.300), with grade ≥3 treatment-related adverse events in 2.4%. MPR was significantly associated with PD-L1 CPS ≥20 (50.0% vs 13.0%, adjusted p=0.023) and CTC clearance (87.5% vs 36.8%, adjusted p=0.033), and multiplex immunofluorescence revealed coupled vascular normalization and immune reprogramming. The authors conclude that neoadjuvant camrelizumab plus apatinib shows promising pathological activity and tolerability, and that PD-L1 CPS, CTC clearance, and microenvironment profiling warrant further investigation as predictive biomarkers.
10.1158/1078-0432.CCR-26-0466

Phase 1 trial and biomarker analysis of Buparlisib with weekly Cisplatin and Radiotherapy in high risk locally advanced squamous cell cancer of the Head and Neck.
▼CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This phase 1 trial evaluated the pan-PI3K inhibitor buparlisib combined with weekly cisplatin and radiotherapy in 23 patients with locally advanced squamous cell head and neck cancer and significant tobacco history. Patients received a 2-week buparlisib run-in followed by standard 70Gy radiotherapy with weekly cisplatin, with genomic sequencing performed on biopsy specimens. The combination was feasible and active, though the standard weekly cisplatin dose of 40 mg/m2 could not be escalated; 5 patients recurred, 3 with PI3K pathway mutations, and responders during run-in showed TRAF3/CYLD loss-of-function mutations. The authors conclude that TRAF3/CYLD mutant SCCHN may be susceptible to PI3K inhibition, while PI3K pathway activation appeared associated with poor outcomes.
10.1158/1078-0432.CCR-21-3677

Neoadjuvant combined immunotherapy with intratumoral TransCon TLR7/8 Agonist and systemic TransCon IL-2 β/y or pembrolizumab in patients with locally advanced oral cancer-a monocentric experience.
▼CANCER IMMUNOL IMMUN · Q1 JOURNAL - RANK #68/326
This single-center report describes six patients with locally advanced oral squamous cell carcinoma treated within the prospective, randomized phase 2 BelieveIT-201 trial, which evaluated neoadjuvant intratumoral TransCon TLR7/8 agonist combined with either pembrolizumab or TransCon IL-2 β/γ (1:1 randomization) followed by surgery. The trial was prematurely terminated, limiting the cohort to six patients (median age 63; median follow-up 81 weeks). Clinical responses included three major responses, two partial responses, and one progressive disease; pathological evaluation showed one complete response, one major response, and four non-responses, with all patients experiencing at least one grade III adverse event and one postoperative death. The authors conclude that the combination was feasible with consistent immune microenvironment remodeling but draw no efficacy conclusions due to the small sample and premature termination.
10.1007/s00262-026-04515-8

A Pilot Clinical Trial of Cetuximab Combined With Tislelizumab as Neoadjuvant Therapy for Locally Advanced Oral Squamous Cell Carcinoma.
▼HEAD NECK-J SCI SPEC · Q1 JOURNAL - RANK #15/67
This prospective single-arm pilot trial evaluated neoadjuvant cetuximab plus tislelizumab in 15 patients with locally advanced oral squamous cell carcinoma (OSCC) who were unsuitable for conventional chemotherapy. Patients received two cycles of the combination before planned surgery, with the primary endpoint being major pathological response (MPR). Results showed an objective response rate of 73.3%, with 5 of 12 surgical patients achieving MPR and 2 achieving pathological complete response. At a median follow-up of 23 months, the 2-year event-free survival and overall survival rates were 66.0% and 78.3%, respectively, with no treatment-related deaths, indicating feasible delivery and encouraging antitumor activity.
10.1002/hed.70463

Aug 31 – Sep 07, 2026

Neoadjuvant triplet chemotherapy enables radiotherapy avoidance in human papillomavirus-associated oropharyngeal cancer: a multicentre Phase II trial.
▼BRIT J CANCER · Q1 JOURNAL - RANK #47/326
This prospective multicenter Phase II trial evaluated neoadjuvant docetaxel, cisplatin, and 5-fluorouracil (NAC-TPF) followed by surgery to avoid postoperative radiotherapy (PORT) or chemoradiotherapy (POCRT) in HPV-associated oropharyngeal squamous cell carcinoma (OPSCC). Thirty-two eligible patients were enrolled, with 30 undergoing transoral surgery after NAC-TPF; R0 resection was confirmed in 31 patients. The centrally reviewed pathological complete response (pCR) rate was 65.6%, and virological complete response was 64.5%, allowing 91% of patients to avoid PORT/POCRT; quality-of-life scores returned to baseline within one year. Although the primary endpoint was not met, the authors concluded that NAC-TPF achieved clinically meaningful pCR and enabled avoidance of adjuvant therapy in most patients. The study is a prospective interventional clinical trial with active treatment, no animal or in-vitro components, and is not a systematic review, protocol, or retrospective analysis.
10.1038/s41416-026-03610-y

A phase II randomized study of proton therapy vs intensity-modulated radiation therapy in patients with unilateral head and neck cancer.
▼JNCI-J NATL CANCER I · Q1 JOURNAL - RANK #44/326
This multicenter, randomized phase II trial compared proton beam radiotherapy (PBRT) with intensity-modulated radiation therapy (IMRT) in 98 adults with resected, well-lateralized head and neck cancers requiring unilateral adjuvant radiotherapy. Patients were randomized 1:1 to receive 60 Gy in 30 fractions, with elective regions to 54 Gy. The primary endpoint was acute grade ≥2 oral mucositis through 3 months, which occurred less frequently with PBRT (7.4% vs 22.7%, P=0.03); acute grade ≥2 dysgeusia was also lower (9.3% vs 31.8%, P=0.005). Late toxicities were uncommon, and 3-year local control, progression-free survival, and overall survival were high and similar between arms, indicating PBRT reduces acute mucosal toxicity.
10.1093/jnci/djag257

CD266+ myofibroblasts mediate resistance to immunochemotherapy through ECM stiffness in head and neck squamous cell carcinoma.
▼CANCER IMMUNOL RES · Q1 JOURNAL - RANK #18/183
This prospective clinical trial (NCT05156970) analyzed single-cell RNA sequencing from 42 samples collected pre- and post-treatment from patients with unresectable/recurrent/metastatic head and neck squamous cell carcinoma (U/R/M HNSCC) receiving immunochemotherapy. The study identified a CD266+ myofibroblast subset that hampered treatment response by enhancing extracellular matrix stiffness via a Piezo1-mediated mechanism, which spatially excluded CD8+ T cells. Mechanistic experiments showed that PIEZO1 inhibition suppressed YAP activation and reduced FAK phosphorylation, and synergized with PD-1 blockade in in vivo models. The findings reveal a stromal-driven immunosuppressive mechanism and propose a potential therapeutic target for U/R/M HNSCC.
10.1158/2326-6066.CIR-25-1379

Lenvatinib plus pembrolizumab for the treatment of patients with non-BRAF mutated anaplastic thyroid cancer: A single center, phase 2 clinical trial.
▼EUR J CANCER · Q1 JOURNAL - RANK #45/326
This single-center phase 2 clinical trial evaluated lenvatinib plus pembrolizumab in 25 patients with BRAF wild-type anaplastic thyroid cancer (ATC), all with distant metastases. The primary endpoint was median overall survival (OS), with secondary endpoints of response rate and progression-free survival (PFS). Median OS was 13 months (95% CI: 7.8-35.6; p<0.01) versus a historical median of 3 months, and median PFS was 5.4 months (95% CI: 3.8-11.0), with an overall response rate of 36% (1 complete, 8 partial responses) at a median follow-up of 18.5 months. The authors conclude the combination demonstrates clinically meaningful OS in this poor-prognosis population, supporting its use as an active therapeutic option (NCT04171622).
10.1016/j.ejca.2026.117013

Aug 24 – Aug 31, 2026

Imaging-Detected Extranodal Extension in p16-Positive Oropharyngeal Cancer: Secondary Analysis of RTOG 1016.
▼JAMA OTOLARYNGOL · Q1 JOURNAL - RANK #3/67
This secondary analysis of the NRG RTOG 1016 prospective clinical trial evaluated the prognostic performance of imaging-detected extranodal extension (iENE) in 586 patients with p16-positive oropharyngeal cancer and clinically node-positive disease. Two expert radiologists reviewed computed tomography simulation scans to document iENE presence, and statistical analyses included Kaplan-Meier, cumulative incidence, and multivariate Cox models, comparing the TNM9 and TNM8 nodal schemas using C-index and AIC. Patients with iENE had inferior 5-year overall survival (79.2% vs 87.0%; difference, 7.8% [95% CI, 1.2%-14.4%]) and progression-free survival (68.8% vs 80.4%; difference, 11.6% [95% CI, 4.1%-19.2%]), with iENE independently associated with worse outcomes on multivariate analysis (OS HR, 1.63; 95% CI, 1.04-2.56). The authors concluded that the updated TNM9 clinical nodal schema, which upstages iENE-positive disease by one category, accurately discriminates outcomes and supports its use in clinical staging.
10.1001/jamaoto.2026.0932

Pre-existing systemic immune state and dynamic myeloid remodeling shape response to neoadjuvant PD-L1 blockade.
▼J IMMUNOTHER CANCER · Q1 JOURNAL - RANK #12/183TOP-TIER
This phase II, open-label, non-randomized window-of-opportunity trial evaluated a single neoadjuvant dose of atezolizumab in 20 patients with resectable head and neck squamous cell carcinoma. The study assessed clinical safety, pathological response, and systemic immune dynamics using fresh blood samples for immune profiling. Pathological tumor regression exceeding 50% was observed in 7 patients (35%), including 5 with major pathological response. Treatment was feasible and safe, with baseline higher frequencies of activated NKT cells and exhausted T cells associated with robust regression, and early marked reduction in mature PMN-MDSC predicting response.
10.1136/jitc-2026-015762

MRI-Guided Reduced-Volume RT for Early-Stage Glottic Cancer: A Prospective Phase 1 Trial with Quantification of Laryngeal Motion.
▼INT J RADIAT ONCOL · Q1 JOURNAL - RANK #14/212
This prospective phase 1 trial evaluated MRI-guided reduced-volume radiotherapy (MRgRT) in patients with stage I/II glottic cancer, delivering either 42.5 Gy/5 fractions or 58.08 Gy/16 fractions based on tumor volume and smoking status. The study enrolled humans and involved active treatment assignment, with coprimary endpoints of feasibility and safety (grade 3+ toxicity rate). At a median follow-up of 10.9 months, MRgRT was feasible in all patients, with no acute or late grade 3+ toxicities and no change in patient-reported outcomes; however, two patients experienced locoregional failure. The authors conclude that MRgRT is feasible and safe, with real-time laryngeal motion tracking revealing frequent beam interruptions and displacement, providing important data for laryngeal RT.
10.1016/j.ijrobp.2026.08.048

Becotatug Vedotin Combined With Pucotenlimab in Platinum- and Immunotherapy-Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma.
▼J CLIN ONCOL · Q1 JOURNAL - RANK #6/326TOP-TIER
This open-label, multicenter, phase I/II clinical trial (Magic-C001) evaluated the combination of the EGFR-directed antibody-drug conjugate becotatug vedotin (BV) and the PD-1 inhibitor pucotenlimab in 31 patients with recurrent or metastatic nasopharyngeal carcinoma resistant to prior platinum and anti-PD-1/PD-L1 therapy. Patients received pucotenlimab 3.0 mg/kg with BV at 1.8-2.3 mg/kg (phase I) or 2.0 mg/kg (phase II) every three weeks. The confirmed objective response rate was 71.0% (95% CI, 52.0-85.8), with a disease control rate of 93.5% (95% CI, 78.6-99.2); median duration of response and progression-free survival were 14.0 and 12.0 months, respectively. Grade ≥3 treatment-related adverse events occurred in 40.6% of patients, with no treatment-related deaths; the authors concluded the regimen shows notable antitumor activity and manageable toxicity, warranting confirmation in an ongoing phase III trial.
10.1200/JCO-26-00640

Concurrent chemotherapy and external radiation therapy (ConCERT): phase 3 noninferiority randomized clinical trial of cisplatin weekly vs every 3 weeks in locally advanced squamous cell carcinoma of the head and neck.
▼JNCI-J NATL CANCER I · Q1 JOURNAL - RANK #44/326
This phase 3 noninferiority randomized clinical trial compared weekly cisplatin (40 mg/m²) to standard 3-weekly cisplatin (100 mg/m²), both with concurrent 70 Gy radiation, in 278 patients with non-nasopharyngeal locally advanced head and neck squamous cell carcinoma. The primary endpoint was 2-year locoregional control (LRC), with a non-inferiority margin of 10%. Two-year LRC rates were 61.3% for the weekly arm and 51.1% for the standard arm (absolute difference 10.2%, one-sided 95% CI lower bound 0.3%), demonstrating non-inferiority. Grade 3+ adverse events (44.7% vs 60.7%, P=0.018) and hospitalizations (20.3% vs 36.8%, P=0.004) were significantly lower in the weekly arm. The authors conclude that weekly low-dose cisplatin is non-inferior with lower toxicity and is a viable treatment option.
10.1093/jnci/djag276

Aug 17 – Aug 24, 2026

Effect of Lithium Mouthwash on Oral Mucositis and Taste Dysfunction in Head and Neck Radiotherapy: The Phase I/II Clinical Trial.
▼INT J RADIAT ONCOL · Q1 JOURNAL - RANK #14/212
This prospective phase I/II clinical trial evaluated lithium-containing mouthwash for oral mucositis (OM) and taste dysfunction (TD) in 175 head and neck cancer patients undergoing radiotherapy. The phase I component determined a 0.15 mol/L dose, and the phase II randomized 160 patients to lithium or placebo mouthwash thrice daily. Severe OM incidence was significantly lower in the lithium group (34.2% vs. 52.1%, P=.0304), with delayed onset (median not reached vs. 35 days, P=.0262) and improved TD, while adverse events were similar. The authors concluded that lithium mouthwash is safe and effective for reducing severe OM and may ameliorate radiation-induced TD.
10.1016/j.ijrobp.2026.08.030

Clinical Efficacy of Neurorrhaphy in Anterolateral Thigh Flap Reconstruction for Tongue Cancer Defects: A Randomized Controlled Trial.
▼ANN SURG ONCOL · Q1 JOURNAL - RANK #39/312
This randomized controlled trial evaluated the efficacy of neurorrhaphy during anterolateral thigh (ALT) flap reconstruction in 40 patients who underwent hemiglossectomy for tongue cancer. Patients were assigned to either the ALT group (n=19) without nerve anastomosis or the N-ALT group (n=21) with simultaneous nerve anastomosis. Functional outcomes including sensory recovery, speech, swallowing, and quality of life were assessed at 2, 6, and 12 months post-surgery. The N-ALT group showed significantly better sensory recovery (two-point discrimination, touch pressure, p<0.05), superior speech and swallowing functions, less flap atrophy, and better quality of life, supporting nerve anastomosis as an effective strategy.
10.1245/s10434-026-20302-2

Danvatirsen plus pembrolizumab versus pembrolizumab for recurrent and/or metastatic head and neck squamous cell carcinoma (PEMDA-HN): a randomized, phase 2 trial.
▼CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This multicenter, randomized, open-label, phase 2 trial evaluated whether adding danvatirsen, a STAT3-targeting antisense oligonucleotide, to pembrolizumab improves outcomes versus pembrolizumab alone in first-line recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) with PD-L1 CPS ≥1. Patients were stratified by CPS and randomized 2:1 to danvatirsen plus pembrolizumab (n=45) or pembrolizumab alone (n=21). Primary endpoint was overall response rate (ORR) per RECIST v1.1; enrollment was stopped early due to lack of response. Final ORRs were 15.6% and 14.3% for the combination and monotherapy arms, respectively (risk difference 1.3, P=1.0), with increased treatment-emergent adverse events in the combination arm (97.8% vs 85.7%). The authors concluded that combination therapy did not improve ORR and that further exploration of STAT3-targeted approaches is needed.
10.1158/1078-0432.CCR-26-0819

T cell receptor repertoire dynamics and newly identified functional regulators of autologous tumor-infiltrating lymphocyte therapy in advanced solid tumors.
▼J TRANSL MED · Q1 JOURNAL - RANK #24/195
This phase I investigator-initiated trial evaluated the safety, feasibility, and preliminary efficacy of autologous tumor-infiltrating lymphocyte (TIL) therapy in twelve Asian patients with advanced melanoma, cervical, lung, or head and neck cancers who had progressed after standard therapies. Patients received lymphodepletion chemotherapy, TIL infusion, and high-dose IL-2, with tumor assessments per RECIST 1.1. The objective response rate was 33.3% (4/12), including one complete response and three partial responses, with a disease control rate of 75% (9/12). TCR sequencing showed dynamic clonal remodeling in responders, and CRISPR-mediated knockout of ASS1 or CEP20 enhanced TIL antitumor function, suggesting these genes as potential targets to improve TIL therapy.
10.1186/s12967-026-08781-z

Acute radiation dermatitis during head-and-neck radiotherapy: VMAT vs IMPT.
▼J CHIN MED ASSOC · Q1 JOURNAL - RANK #78/332
This prospective non-randomized cohort study compared acute radiation dermatitis (ARD) and skin-related quality of life (QoL) between volumetric modulated arc therapy (VMAT) and intensity-modulated proton therapy (IMPT) in 158 adults with newly diagnosed head-and-neck cancer (113 VMAT, 45 IMPT). Skin-related QoL was assessed using Skindex-16 at baseline, end of RT, and 3 months post-RT, while ARD was graded weekly using CTCAE v5.0. Clinically meaningful Skindex-16 Global score worsening occurred in 37.0% of patients at end of RT, with no significant difference between modalities (grade 2 ARD: 30.0% vs 29.5%; grade 3: 7.0% vs 4.8%; p=0.85). Advanced nodal disease (N2-3) and RT dose ≥66 Gy independently predicted worse outcomes, supporting risk-adapted planning and proactive supportive care.
10.1097/JCMA.0000000000001413

Induction TPF versus adjuvant PF after CCRT in locally advanced nasopharyngeal carcinoma: A multicenter, randomized controlled phase III clinical trial.
▼RADIOTHER ONCOL · Q1 JOURNAL - RANK #22/212
This multicenter, randomized controlled phase III clinical trial (NCT03574324) conducted across 4 Chinese institutions enrolled 266 patients with locally advanced nasopharyngeal carcinoma to compare TPF induction chemotherapy (IC) followed by concurrent chemoradiotherapy (CCRT) versus CCRT followed by PF adjuvant chemotherapy (AC). The primary endpoint was progression-free survival (PFS), with secondary endpoints including overall survival, locoregional relapse-free survival, distant metastasis-free survival, and toxicity. At a median follow-up of 39 months, the 3-year PFS was similar between groups (79% IC vs. 74.5% AC, P=0.454), with no significant differences in secondary survival outcomes. While IC reduced CCRT-related toxicities (nausea/vomiting, swallowing issues, dryness), it increased grade 3-4 leukopenia (44.27% vs. 21.88%) and neutrophilia (59.54% vs. 18.75%), leading to the conclusion that IC does not improve survival but alters the toxicity profile.
10.1016/j.radonc.2026.111746