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

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.

NCT Number	NCT07445048
Lead Sponsor	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Conditions	Head & Neck Squamous Cell Carcinoma, Head & Neck Cancer, Postoperative Adjuvant Treatment
Enrollment	370 participants
Start Date	2026-03-04
Primary Completion	2028-03-05 (estimated)
Study Completion	2031-03-05 (estimated)
Updated on ClinicalTrials.gov	2026-04-17