drugset / Trial / NCT06459921
Efficacy and Safety of Neoadjuvant Sintilimab Plus FLOT Versus Sintilimab Plus SOX Phase II Clinical Trial for Patients With Locally Advanced Gastric Cancer
Non-randomizedParallel-groupTriple-blindTreatment
Summary
This study aims to investigate the efficacy and safety of Sintilimab combined with FOLT versus Sintilimab combined with SOX in patients with locally advanced gastric cancer. The research design is intended to observe the comparison of conversion therapy effects, disease-free survival, R0 resection rate, and safety evaluation between the two groups.
Timeline
- Start
- 2024-12-01
- Primary completion
- 2026-07-01
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | OXA | Unknown | 85 mg/m2 | Intravenous |
| Subject | OXA | Unknown | 130 mg/m2 | Intravenous |
| Subject | S-1 | Small molecule | 80 mg/m2 | Oral |
| Comparator | TXT | Unknown | 50 mg/m2 | Intravenous |
| Comparator | fluorouracil | Small molecule | 2600 mg/m2 | Intravenous |
| Background | Sintilimab | Monoclonal antibody | 200 mg | — |
| Comparator | folic acid | Other / unclassified | 200 mg/m2 | Intravenous |