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

Sponsor
Yu jiren
Study ID
NCT05872685
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • S1 — DRUG
    S-1 orally intake as perioperative chemotherapy
  • Oxaliplatin — DRUG
    Oxaliplatin (130 mg/m2) infusion as perioperative chemotherapy
  • Serplulimab — DRUG
    Perioperative serplulimab, 300 mg IV infusion
  • Placebo — DRUG
    Perioperative placebo, 300 mg IV infusion

Study Details

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

Key Dates

Start date
Dec 24, 2023
Status verified
Jan 2024
Primary completion
Apr 30, 2026
Completion
Apr 30, 2029

Study Design

Enrollment
314 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A (Chemotherapy+Serplulimab )
    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.
  • Active Comparator: Group B (Chemotherapy+Placebo )
    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.

Primary Outcome Measure

Rate of pathological complete responses (pCR) [ Time Frame: From enrollment to surgery after pre-operative treatment (up to approximately 36 months) ]

Central Contacts