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A Randomized, Double-blinded, Multicenter, Phase III Clinical Study of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) Combined With Chemotherapy Versus Placebo Combined With Chemotherapy for Neoadjuvant/Adjuvant Treatment of Gastric Cancer

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Trial Profile

A Randomized, Double-blinded, Multicenter, Phase III Clinical Study of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) Combined With Chemotherapy Versus Placebo Combined With Chemotherapy for Neoadjuvant/Adjuvant Treatment of Gastric Cancer

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 13 Jan 2026

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At a glance

  • Drugs Serplulimab (Primary) ; Gimeracil/oteracil/tegafur; Oxaliplatin
  • Indications Adenocarcinoma; Gastric cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ASTRUM-006
  • Sponsors Shanghai Henlius Biotech

Most Recent Events

  • 25 Dec 2025 According to Shanghai Henlius Biotech media release, data from this trial will be presented at The 2026 American Society of Clinical Oncology Gastrointestinal Cancers Sympotsium (ASCO GI 2026) will be held in San Francisco.
  • 12 Dec 2025 According to Henlius Biotech media release, based upon positive results from a phase 3 registrational trial announced that the New Drug Application (NDA) for Hetronifly in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by adjuvant treatment after surgery, for PD-L1 positive, operable gastric cancer patients, has been accepted by the National Medical Products Administration (NMPA) and granted Priority Review.
  • 21 Nov 2025 Primary endpoint (EFS) has been met, according to Shanghai Henlius Biotech media release.

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