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NOT YET RECRUITING
NCT07699939
PHASE2

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

Sponsor: National Cancer Center, Japan

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

136

Start Date

2026-07-15

Completion Date

2029-06-30

Last Updated

2026-07-14

Healthy Volunteers

No

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.

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