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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: 11 Jun 2025

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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

  • 06 Jun 2025 According to a Shanghai Henlius Biotech media release, Dr. Jaffer A. Ajani is the lead principal investigator of the HLX22-GC-301 study.
  • 26 May 2025 According to a Shanghai Henlius Biotech media release, study design of this trial will be presented at the 2025 ASCO Annual Meeting.
  • 26 May 2025 According to a Shanghai Henlius Biotech media release, company has obtained investigational new drug (IND) approvals in China, the U.S, Japan, Australia, Korea and EU Germany, etc.

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