drugset / Trial / NCT04782791
Nivolumab, S-1 Combined With Oxaliplatin Versus Nivolumab as Neoadjuvant Therapy in Advanced Gastric Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The trial is a prospective, randomized, controlled phase Ⅱ study which will be conducted in Chinese PLA General Hospital, Beijing, China. Patients with eligibility will enrolled and assigned into either group A for 9 weeks of nivolumab, S-1 combined with oxaliplatin (Nivo+SOX) followed by D2 surgery and group B for 9 weeks of nivolumab followed by D2 surgery. The primary endpoint is the safety assessed by recording adverse events and the secondary endpoints are response rate, disease control rate, pathological complete response rate, D2 rate and R0 rate.
Timeline
- Start
- 2022-05-01
- Primary completion
- 2023-12-31
- Completion
- 2024-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Nivolumab | Monoclonal antibody | 360 mg | 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 |