A Multicenter, Randomized, Controlled, Open-Label, Phase III Clinical Trial.To evaluate the efficacy and safety of postoperative radiotherapy combined with Nimotuzumab followed by Benmelstobart in high-risk patients with head and neck squamous cell carcinoma who are ineligible for cisplatin chemotherapy.
The primary endpoint is disease-free survival (DFS). A total of 185 patients will be enrolled in both the study group and the control group, respectively, with a total planned enrollment of 370 patients. Enrollment is expected to be completed within 2 years, followed by a 3-year follow-up period after the last patient is enrolled.
Age ≥ 18 years.
Patients ineligible for cisplatin chemotherapy, defined as meeting any of the following:① Age > 70 years;② Renal insufficiency (creatinine clearance < 50 mL/min; criterion ⑩ below does not apply if this criterion is met);③ Severe tinnitus or hearing impairment (requiring hearing aid, or audiometry showing ≥ 25 dB loss at two consecutive frequencies);④ Unable to receive intravenous hydration (e.g., due to cardiac dysfunction or other comorbidities, as judged by the investigator);⑤ Neuropathy > Grade 1;⑥ Patient refusal of chemotherapy.
Histologically confirmed locally advanced head and neck squamous cell carcinoma (AJCC 8th edition Stage III-IVB), including oral cavity cancer, HPV-negative/unrelated oropharyngeal cancer, hypopharyngeal cancer, and laryngeal cancer.
4 metastatic lymph nodes, or multiple perineural invasions.
Prior radiotherapy for head and neck cancer before enrollment.
Prior treatment with similar immunological or targeted agents.
Participation in another interventional clinical trial within 30 days prior to screening.
Evidence of distant metastasis.
Parallel
Bemcentinib
Drug1200 mg on Day 1, every 3 weeks (Q3W) for a total of 17 cycles, initiated 3-4 weeks after completion of radiotherapy.
Nimotuzumab
Drug200 mg on Day 1, once weekly (QW) for a total of 7 cycles.
radiotherapy
RadiationIntensity-modulated radiation therapy (IMRT) will be administered at a total dose of 60-66 Gy (2 Gy per fraction, 30-33 fractions). A boost to a clearly defined high-risk area may be applied at the investigator's discretion.
Disease-Free Survival (DFS
Overall Survival (OS)
Locoregional Recurrence-Free Survival (LRRFS)
Distant Metastasis-Free Survival (DMFS)
Change From Baseline in Global Quality of Life Score (EORTC QLQ-C30)
Assessed using EORTC QLQ-C30 (V3) questionnaires.The EORTC QLQ-C30 is a 30-item validated questionnaire designed to assess the quality of life in cancer patients. It includes five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea/vomiting), a global health status/quality of life scale, and six single items assessing additional symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All scales and single items are scored on a range from 0 to 100. For the functional scales and global health status scale, higher scores indicate better quality of life or functioning. For the symptom scales and single items, higher scores indicate worse symptoms or greater severity.
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