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Perioperative HLX10 (Serplulimab) With S-1+Oxaliplatin (SOX) in Locally Advanced and PD-L1-Positive Gastric or Esophagogastric Junction Adenocarcinoma

NCT07699939 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2026-08-05

No results posted yet for this study

Summary

To evaluate the clinical efficacy of perioperative treatment with S-1 + oxaliplatin (SOX)+ HLX10 compared with SOX as the control in patients with cT3-4N1-3M0 PD-L1-positive (CPS ≥ 5) locally advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, in a placebo-controlled, double-blind, randomized phase II investigator-initiated clinical study.

Conditions

  • Gastric Adenocarcinoma
  • Gastroesophageal Junction (GEJ) Adenocarcinoma

Interventions

DRUG

serplulimab

Patients receive perioperative treatment with S-1 plus oxaliplatin (SOX) in combination with Serplulimab.

DRUG

Placebo

Patients receive perioperative treatment with S-1 plus oxaliplatin (SOX) in combination with placebo.

Sponsors & Collaborators

  • National Cancer Center, Japan

    lead OTHER_GOV

Principal Investigators

  • Ken Kato, M.D., Ph.D. · National Cancer Center, Japan

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
2026-07-15
Primary Completion
2028-11-30
Completion
2029-06-30

Countries

  • Japan
  • South Korea

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 NCT07699939 on ClinicalTrials.gov