drugset / Trial / NCT07445048
Postoperative Radiotherapy Combined With Nimotuzumab Followed by Benmelstobart in High-Risk Patients With Head and Neck Squamous Cell Carcinoma
Phase 3
Recruiting
370 enrolled
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2026-03-04
- Primary completion
- 2028-03-05
- Completion
- 2031-03-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bemcentinib | Small molecule | 1200 mg | — |
| Subject | Nimotuzumab | Monoclonal antibody | 200 mg | — |