MedTrace Logo

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

NCT05872685 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 314

Last updated 2024-01-17

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Yu jiren

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-24
Primary Completion
2026-04-30
Completion
2029-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05872685 on ClinicalTrials.gov