NCT05872685

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 314 (estimated)
• Sponsor: Yu jiren · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Adenocarcinoma of the Stomach
• Adenocarcinoma of Esophagogastric Junction
• Proficient Mismatch Repair

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-12-24
• Primary completion: 2026-04-30
• Completion: 2029-04-30
• First posted: 2023-05-24
• Last updated: 2024-01-17

Locations

5 sites across 1 country: China