Study #2025-0093
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
MD Anderson Study Status
Enrolling
Treatment Agent
HLX22, Trastuzumab, Oxaliplatin, Capecitabine, Pembrolizumab
Description
This is a double-blind, randomized, multiregion, comparative phase Ⅲ clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with HER2-positive locally advanced/metastatic adenocarcinoma of the gastric and/or gastroesophageal junction (G/GEJ).Eligible subjects will be randomized to the two groups based on a 1:1 ratio. Enrolled subjects shall be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).
Resources and Links
Phone Number: 1-877-MDA-6789
Information and next steps
Disease:
Gastroesophageal-junction Cancer, Monoclonal Antibody, Gastric Cancer, HER2-positive Gastric Cancer
Study phase:
Phase III
Physician name:
Mariela Blum Murphy
Department:
Gastrointestinal Medical Oncology
For general questions about clinical trials:
1-877-632-6789
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