drugset / Trial / NCT07601737
Nimotuzumab Combined With Immunotherapy and Chemotherapy in the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma
Phase 2
Recruiting
182 enrolled
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized controlled, phase II clinical study designed to explore the efficacy and safety of nimotuzumab combined with immunotherapy and chemotherapy as neoadjuvant treatment for locally advanced head and neck squamous cell carcinoma (LA-HNSCC). The primary endpoint of the study is the 2-year event-free survival (EFS) rate. Enrollment is expected to be completed within 2 years; all patients will be followed up for at least 2 years after the last patient is enrolled.
Timeline
- Start
- 2026-04-20
- Primary completion
- 2028-04-30
- Completion
- 2030-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | 5 unknown | — |
| Subject | Cisplatin | Other / unclassified | 40 mg/m2 | — |
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | — |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | — |
| Subject | Nimotuzumab | Monoclonal antibody | 200 mg | — |
| Subject | Nimotuzumab | Monoclonal antibody | 400 mg | — |
| Subject | Paclitaxel | Small molecule | 180 mg/m2 | — |
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | — |