RecruitingPhase 2NCT07699939

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

Perioperative HLX10 (Serplulimab) With S-1+Oxaliplatin (SOX) in Locally Advanced and PD-L1-Positive Gastric or Esophagogastric Junction Adenocarcinoma: A Randomized Phase 2 Investigator-Initiated Trial

Sponsor

National Cancer Center, Japan

Enrollment

136 participants

Start Date

Jul 15, 2026

Study Type

INTERVENTIONAL

Conditions

Gastric Adenocarcinoma Gastroesophageal Junction (GEJ) Adenocarcinoma

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called serplulimab for people with gastric adenocarcinoma and gastroesophageal junction (gej) adenocarcinoma. The study is currently recruiting participants at 18 locations. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGserplulimab

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

DRUGPlacebo

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

Locations(18)

Chiba Cancer Center

Chiba, Chiba, Japan

Kyushu Cancer Center

Fukuoka, Fukuoka, Japan

Gifu University Hospital

Gifu, Gifu, Japan

Gunma University Hospital

Maebashi, Gunma, Japan

Hiroshima University Hospital

Hiroshima, Hiroshima, Japan

St. Marianna University Hospital

Kawasaki, Kanagawa, Japan

Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

Saitama Prefectural Cancer Center

Ina, Kitaadachi-gun, Japan

Osaka International Cancer Institute

Osaka, Osaka, Japan

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, Osaka, Japan

Saitama Medical University International Medical Center

Hidaka, Saitama, Japan

Shizuoka Cancer Center

Nagaizumi-chō, Sunto-gun, Japan

National Cancer Center Hospital

Chuo Ku, Tokyo, Japan

Cancer Institute Hospital of JFCR

Koto-Ku, Tokyo, Japan

National Cancer Center Korea

Goyang-si, Gyeonggi-do, South Korea

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Seoul St. Mary's Hospital

Seocho, Seoul, South Korea

Asan Medical Center

Songpa-dong, South Korea

View Full Details on ClinicalTrials.gov

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NCT07699939

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