Clinical Research Directory
Browse clinical research sites, groups, and studies.
Postoperative Radiotherapy Combined With Nimotuzumab Followed by Bemcentinib in High-Risk Patients With Head and Neck Squamous Cell Carcinoma
Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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 Bemcentinib 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.
Official title: A Multicenter, Randomized, Controlled, Open-Label, Phase III Clinical Trial of Postoperative Radiotherapy Combined With Nimotuzumab Followed by Bemcentinib in High-Risk Patients With Head and Neck Squamous Cell Carcinoma Who Are Ineligible for Cisplatin Chemotherapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
370
Start Date
2026-03-05
Completion Date
2031-03-05
Last Updated
2026-03-03
Healthy Volunteers
No
Interventions
Bemcentinib
1200 mg on Day 1, every 3 weeks (Q3W) for a total of 17 cycles, initiated 3-4 weeks after completion of radiotherapy.
Nimotuzumab
200 mg on Day 1, once weekly (QW) for a total of 7 cycles.
radiotherapy
Intensity-modulated radiation therapy (IMRT) will be administered at a total dose of 60-66 Gy (2 Gy per fraction, 30-33 fractions). A boost to a clearly defined high-risk area may be applied at the investigator's discretion.