eligibility_summary
Eligible: patients with unresectable advanced or recurrent HER2-overexpressing gastric cancer starting this specific anti-HER2 drug for the first time after its launch, treatment cannot be trastuzumab (Herceptin) or its biosimilars. Exclusion criteria: none specified.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Trastuzumab BS (Trastuzumab Biosimilar 3, recombinant humanized IgG1 monoclonal antibody), given IV as 4 mg/kg load then 2 mg/kg weekly (Regimen A) or 8 mg/kg load then 6 mg/kg every 3 weeks (Regimen B, with chemotherapy for gastric cancer). Mechanism of action: binds the HER2/ErbB2 receptor (extracellular domain), inhibits receptor activation/dimerization and shedding, suppresses downstream signaling (PI3K/AKT/mTOR and RAS/RAF/MEK/ERK), and induces antibody-dependent cellular cytotoxicity (ADCC) via FcγR-bearing immune effector cells (notably NK cells). Targets: HER2-overexpressing gastric cancer cells and the HER2 signaling pathway.