drugset / Trial / NCT07535567

Postoperative Radiotherapy With Nimotuzumab ± Benmelstobart in Intermediate-Risk Head and Neck Squamous Cell Carcinoma

NCT07535567

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

EvaluationDrugModalityDoseRoute
Subject Benmelstobart Monoclonal antibody 1200 mg
Comparator Nimotuzumab Monoclonal antibody 200 mg