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A Randomized, Double-blinded, Multicenter, Phase III Clinical Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab and Chemotherapy (XELOX) Versus Trastuzumab and Chemotherapy (XELOX) With or Without Pembrolizumab for the First Line Treatment of Locally Advanced or Metastatic Gastroesophageal Junction and Gastric Cancer

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Trial Profile

A Randomized, Double-blinded, Multicenter, Phase III Clinical Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab and Chemotherapy (XELOX) Versus Trastuzumab and Chemotherapy (XELOX) With or Without Pembrolizumab for the First Line Treatment of Locally Advanced or Metastatic Gastroesophageal Junction and Gastric Cancer

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 05 Mar 2026

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At a glance

  • Drugs HLX 22 (Primary) ; Capecitabine; Oxaliplatin; Pembrolizumab; Trastuzumab
  • Indications Adenocarcinoma; Gastric cancer; Oesophageal cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Shanghai Henlius Biotech

Most Recent Events

  • 02 Feb 2026 According to Shanghai Henlius Biotech media release, the company successfully held an offline investigator meeting for its HLX22-GC-301 study in San Francisco, USA.
  • 09 Jan 2026 According to Shanghai Henlius Biotech media release, data from this study were presented at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI 2026).
  • 09 Jan 2026 Results presented in a Shanghai Henlius Biotech Media Release.

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