NCT07535567

Postoperative Radiotherapy With Nimotuzumab ± Benmelstobart in Intermediate-Risk Head and Neck Squamous Cell Carcinoma: A Randomized Controlled Trial

Postoperative Radiotherapy And Nimotuzumab With or Without Benmelstobart Adjuvant Therapy in Patients With Head and Neck Squamous Cell Carcinoma Having Intermediate-Risk Pathological Factors: A Multicenter Prospective Randomized Controlled Study

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 386 (estimated)
• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Multicenter, Randomized, Controlled, Open-Label, Phase II/III Clinical Trial to evaluate the efficacy and safety of postoperative radiotherapy and Nimotuzumab with/without Bemcentinib in intermediate-risk pathological patients with head and neck squamous cell carcinoma.The primary endpoint is 3-year disease-free survival (DFS). A total of 193 patients will be enrolled in both the study group and the control group, respectively, with a total planned enrollment of 386 patients.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Nimotuzumab	Nimotuzumab: 200 mg on Day 1, once weekly (QW) for a total of 6 cycles.
DRUG	Nimotuzumab, Benmelstobart	Nimotuzumab: 200 mg on Day 1, once weekly (QW) for a total of 6 cycles. Bemcentinib: 1200 mg on Day 1, every 3 weeks (Q3W) for a total of 9 cycles, initiated 3-4 weeks after completion of radiotherapy.
RADIATION	Postoperative Radiotherapy	Intensity-modulated radiation therapy (IMRT) will be administered at a total dose of 60Gy (2 Gy per fraction, 30 fractions)

Timeline

• Start date: 2026-05-05
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2026-04-17
• Last updated: 2026-04-17