drugset / Trial / NCT03691454
Compare Neoadjuvant DOS Combined With Toripalimab Versus SOX Combined With Toripalimab in Locally Advanced Gastric Adenocarcinoma
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized, multicenter, controlled, adaptive phase II/III clinical study. The aim is to compare neoadjuvant chemotherapy with docetaxel, oxaliplatin, and S-1 (DOS) plus toripalimab versus oxaliplatin and S-1 (SOX) plus toripalimab in patients with locally advanced gastric adenocarcinoma.
Timeline
- Start
- 2018-06-28
- Primary completion
- 2026-09-30
- Completion
- 2027-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 50 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Subject | S-1 | Small molecule | 40 mg | Oral |
| Subject | S-1 | Small molecule | 50 mg | Oral |
| Subject | S-1 | Small molecule | 60 mg | Oral |
| Subject | Toripalimab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Toripalimab | Monoclonal antibody | 240 mg | Intravenous |