drugset / Trial / NCT07535567
Postoperative Radiotherapy With Nimotuzumab ± Benmelstobart in Intermediate-Risk Head and Neck Squamous Cell Carcinoma
Phase 2/3
Not yet recruiting
386 enrolled
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
RandomizedParallel-groupOpen-labelTreatment
Summary
A multicenter, randomized, controlled, open-label, Phase II/III clinical trial designed to evaluate the efficacy and safety of postoperative radiotherapy combined with Nimotuzumab,with or without Bemcentinib, in postoperative head and neck squamouscell cancer patients with intermediate-risk pathological factor. The primary endpoint is the 3-year disease-freesurvival (DFS). A total of 193 patients will be enrolled in both the experimental and control groups, resulting in a total planned enrollment of 386 patients.
Timeline
- Start
- 2026-05-05
- Primary completion
- 2028-12-31
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Benmelstobart | Monoclonal antibody | 1200 mg | — |
| Comparator | Nimotuzumab | Monoclonal antibody | 200 mg | — |