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

PHASE2RecruitingINTERVENTIONAL
Enrollment

314

Participants

Timeline

Start Date

December 24, 2023

Primary Completion Date

April 30, 2026

Study Completion Date

April 30, 2029

Conditions
Adenocarcinoma of the StomachAdenocarcinoma of Esophagogastric JunctionProficient Mismatch Repair
Interventions
DRUG

S1

S-1 orally intake as perioperative chemotherapy

DRUG

Oxaliplatin

Oxaliplatin (130 mg/m2) infusion as perioperative chemotherapy

DRUG

Serplulimab

Perioperative serplulimab, 300 mg IV infusion

DRUG

Placebo

Perioperative placebo, 300 mg IV infusion

Trial Locations (5)

310003

RECRUITING

The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou

NOT_YET_RECRUITING

The Second Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou

315048

NOT_YET_RECRUITING

Ningbo Medical Center LiHuiLi Hospital, Ningbo

317099

NOT_YET_RECRUITING

Taizhou Hospital, Taizhou

323000

NOT_YET_RECRUITING

Lishui Central Hospital, Lishui

All Listed Sponsors
lead

Yu jiren

OTHER