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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: 20 May 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

  • 27 Apr 2026 According to a Henlius Biopharmaceuticals media release, marketing application of Hetronifly has been accepted and included in priority review, with approval expected in 2026
  • 27 Apr 2026 According to a Henlius Biopharmaceuticals media release, data from this trial will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting will be held in Chicago, USA, from May 29th to June 2nd.
  • 24 Apr 2026 According to Shanghai Henlius Biotech media release, data from the trial were presented at the 2026 Chinese Society of Clinical Oncology (CSCO) Guidelines Meeting.

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