Phase III Trial of Postoperative Radiotherapy with Nimotuzumab and Bemcentinib for High-Risk Head and Neck Squamous Cell Carcinoma Patients Not Eligible for Cisplatin Chemotherapy

What this Trial Is About

Researchers are evaluating the safety and effectiveness of postoperative radiotherapy combined with Nimotuzumab followed by Bemcentinib in patients with high-risk head and neck squamous cell carcinoma who cannot receive cisplatin chemotherapy. This Phase III multicenter clinical trial aims to improve disease-free survival in this specific group of patients. A total of 370 patients will be enrolled and monitored over a planned period of 3 years after the last patient joins the study. Participants will be randomly assigned to either the study group or the control group. The study group will receive intensity-modulated radiation therapy IMRT at doses of 60-66 Gy over 30-33 sessions, along with weekly Nimotuzumab injections for 7 weeks. After radiotherapy, Bemcentinib will be given orally at 1200 mg every 3 weeks for up to 17 cycles. The control group will receive standard postoperative care without this combination treatment. During the trial, patients will undergo regular assessments including imaging to check for cancer recurrence or spread, blood tests, and quality of life questionnaires. Researchers will monitor disease-free survival as the main outcome, along with overall survival, recurrence rates, distant metastasis, and treatment side effects. The study includes safety monitoring for adverse events during treatment and follow-up for up to 3 years. Participants are expected to complete the study with ongoing evaluations of health and quality of life.

Postoperative Radiotherapy Combined With Nimotuzumab Followed by Benmelstobart in High-Risk Patients With Head and Neck Squamous Cell Carcinoma