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Studies

Interventional Recruiting Phase 2

NCT07699939 on ClinicalTrials.gov

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

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

  • Sponsor: National Cancer Center Hospital (Japan, Tokyo)
  • Enrollment: 136 (Estimated)
  • Study start: 2026-07-15 (Actual)
  • Primary completion: 2028-11-30 (Estimated)
  • Study completion: 2029-06-30 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief 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

Intervention / Treatment

  • Drug: serplulimab
  • Drug: Placebo

Primary Outcome Measures

  • Pathological complete response (pCR) rate by central pathology review (Approximately 4-5 months after randomization (after surgery))
    In the ITT population, this is defined as the proportion of subjects with complete disappearance of the tumor based on central pathology review.

Countries

Japan, South Korea

Locations and Investigators

  • Chiba Cancer Center, Chiba, Japan (Recruiting)
    • Keiko Minashi, M.D.
  • Kyushu Cancer Center, Fukuoka, Japan (Recruiting)
    • Yasue Kimura, M.D.
  • Gifu University Hospital, Gifu, Japan (Not yet recruiting)
    • Akitaka Makiyama, M.D.
  • Gunma University Hospital, Maebashi, Japan (Not yet recruiting)
    • Daisuke Takahari, M.D.
  • Hiroshima University Hospital, Hiroshima, Japan (Not yet recruiting)
    • Kazuteru Tanabe
  • St. Marianna University Hospital, Kawasaki, Japan (Recruiting)
    • Yohei Kubota, M.D.
  • Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center, Yokohama, Japan (Not yet recruiting)
    • Mitsuhiro Furuta, M.D.
  • Saitama Prefectural Cancer Center, Ina, Japan (Not yet recruiting)
    • Hiroki Hara, M.D.
  • Osaka International Cancer Institute, Osaka, Japan (Not yet recruiting)
    • Kazuyoshi Yamamoto, M.D.
  • Osaka Medical and Pharmaceutical University Hospital, Takatsuki, Japan (Recruiting)
    • Toshifumi Yamaguchi, M.D.
  • Saitama Medical University International Medical Center, Hidaka, Japan (Not yet recruiting)
    • Shinichi Sakuramoto, M.D.
  • Shizuoka Cancer Center, Nagaizumi-chō, Japan (Not yet recruiting)
    • Takeshi Kawakami
  • National Cancer Center Hospital, Chuo Ku, Japan (Recruiting)
    • Hidekazu Hirano, M.D.
  • Cancer Institute Hospital of JFCR, Koto-Ku, Japan (Not yet recruiting)
    • Akira Oki, M.D.
  • National Cancer Center Korea, Goyang-si, South Korea (Not yet recruiting)
  • Ajou University Hospital, Suwon, South Korea (Not yet recruiting)
  • Seoul St. Mary's Hospital, Seocho, South Korea (Not yet recruiting)
  • Asan Medical Center, Songpa-dong, South Korea (Not yet recruiting)

Study Officials