drugset / Trial / NCT04882462
Sintilimab and Nimotuzumab Combined With Chemotherapy for the Treatment of R/M HNSCC.
Phase 2
Unknown
100 enrolled
The First Affiliated Hospital of Soochow University
Biotech Pharmaceutical Co., Ltd. · collabCinda Biopharmaceutical (Suzhou) Co., Ltd. · collab
NaSingle-groupOpen-labelTreatment
Summary
This clinical study is designed as a prospective, open-label, single arm, multicenter study to evaluate the clinical efficacy and safety of Sintilimab and Nimotuzumab in combination with chemotherapy in patients with newly diagnosed recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). The main endpoint is progression free survival (PFS); the secondary endpoint are objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety.
Timeline
- Start
- 2021-05-01
- Primary completion
- 2021-11-30
- Completion
- 2022-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nimotuzumab | Monoclonal antibody | 400 mg | Intravenous |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |