Phase II Study of Perioperative Chemotherapy with Serplulimab or Placebo for Locally Advanced Gastric Adenocarcinoma with Proficient Mismatch Repair

What this Trial Is About

Researchers are evaluating perioperative chemotherapy combined with serplulimab or placebo for patients with locally advanced gastric adenocarcinoma that has proficient mismatch repair. This phase II, multi-center, double-blinded, randomized trial aims to compare the safety and effectiveness of adding serplulimab to the standard SOX chemotherapy regimen in this patient population. Participants receive chemotherapy with oxaliplatin and S-1 in cycles repeated every 21 days, three cycles before surgery and three cycles after surgery. One group receives serplulimab 300 mg by intravenous infusion on Day 1 of each cycle, while the other receives a placebo infusion on the same schedule. Both treatments are administered alongside the chemotherapy regimen. During the study, participants will be closely monitored from enrollment through surgery and follow-up. Researchers will assess pathological complete response rates after preoperative treatment, overall survival, progression-free survival, and the incidence of adverse events. The main outcome will be measured up to approximately 36 months, with safety monitoring continuing up to 27 months and overall follow-up lasting up to 60 months.

Perioperative Chemotherapy Combined With Serplulimab or Placebo for pMMR Locally Advanced Gastric Adenocarcinoma (FOCUS-05)