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Oxaliplatin

Drug: Oxaliplatin，S-1，Serplulimab

Chemotherapy (SOX): Oxaliplatin, administered as a 2-hour intravenous infusion (130 mg/m2) S-1, orally twice daily for 2 weeks followed by a 7-day rest period. The dose of S-1 was 80 mg/day for body surface area less than 1.25 m2, 100 mg/day for body surface area greater than or equal to 1.25 to less than 1.5 m2, and 120 mg/day for body surface area greater than or equal to 1.5 m2 Chemotherapy will be repeated each 21 day for 3 cycles prior to surgery and 3 cycles after surgery.

Serplulimab: 300 mg IV infusion on Day 1 of each 21 day cycle for 3 cycles prior to surgery and 3 cycles after surgery.

Drug: Oxaliplatin，S-1，Placebo

Chemotherapy (SOX): Oxaliplatin, administered as a 2-hour intravenous infusion (130 mg/m2) S-1, orally twice daily for 2 weeks followed by a 7-day rest period. The dose of S-1 was 80 mg/day for body surface area less than 1.25 m2, 100 mg/day for body surface area greater than or equal to 1.25 to less than 1.5 m2, and 120 mg/day for body surface area greater than or equal to 1.5 m2 Chemotherapy will be repeated each 21 day for 3 cycles prior to surgery and 3 cycles after surgery.

Placebo: 300 mg IV infusion on Day 1 of each 21 day cycle for 3 cycles prior to surgery and 3 cycles after surgery.

S-1 orally intake as perioperative chemotherapy

Oxaliplatin (130 mg/m2) infusion as perioperative chemotherapy

Perioperative serplulimab, 300 mg IV infusion

Serplulimab

Perioperative placebo, 300 mg IV infusion

Placebo

Jiren Yu

Jian Chen

Hongtao Xu

Weiming Yu

Shenkang Zhou

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

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

Perioperative S-1 Plus Oxaliplatin Combined With Serplulimab or Placebo for Locally Advanced Gastric Adenocarcinoma With Proficient Mismatch Repair: a Prospective, Multi-center, Double-blinded, Randomized Placebo-controlled Study

Percentage of patients with pCR referring to the total number of enrolled and eligible patients, as evaluated centrally by a reference pathologist.

Overall survival (OS) will be determined by measuring the time interval from enrollment to the end of follow up or death from any cause

Progression-free survival (PFS) will be defined as the time from enrollment to the end of follow up or the time of disease progression or relapse or death from any cause

The incidences and types of adverse events that occur during treatment will be evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Spots Global Cancer Trial Database for proficient mismatch repair