drugset / Trial / NCT05872685
Perioperative Chemotherapy Combined With Serplulimab or Placebo for pMMR Locally Advanced Gastric Adenocarcinoma (FOCUS-05)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This phase II study is a prospective, multi-center, double-blinded, and randomized trial to compare the efficacy and safety of perioperative SOX plus serplulimab with SOX plus placebo for locally advanced gastric adenocarcinoma with proficient mismatch repair
Timeline
- Start
- 2023-12-24
- Primary completion
- 2026-04-30
- Completion
- 2029-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Subject | S-1 | Small molecule | 80 mg | Oral |
| Subject | S-1 | Small molecule | 100 mg | Oral |
| Subject | S-1 | Small molecule | 120 mg | Oral |
| Subject | Serplulimab | Monoclonal antibody | 300 mg | Intravenous |