eligibility_summary
Eligible: adults ≥19 with pathologically confirmed metastatic/recurrent/unresectable gastric or gastroesophageal adenocarcinoma, HER2-positive (IHC 3+ or IHC 2+ with ISH+), treated with Trastuzumab Deruxtecan as ≥3rd-line. Exclude: HER2-negative, no consent, or received Trastuzumab Deruxtecan as 1st/2nd-line within a clinical trial.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06767436 evaluates real‑world efficacy/safety of trastuzumab deruxtecan (T‑DXd, Enhertu) in HER2‑positive advanced gastric/GEJ adenocarcinoma, third line or later. Drug/intervention: Trastuzumab deruxtecan, an antibody‑drug conjugate (humanized anti‑HER2 IgG1 trastuzumab) linked via a cleavable linker to DXd, a membrane‑permeable topoisomerase I inhibitor (cytotoxic payload). Mechanisms: Binds HER2 (ERBB2) on tumor cells, is internalized, and releases DXd in lysosomes, inhibiting topoisomerase I to cause DNA damage and apoptosis, exhibits a bystander effect. The trastuzumab moiety also blocks HER2 signaling and mediates Fc‑dependent ADCC. Target cells/pathways: HER2‑overexpressing tumor cells (IHC 3+ or 2+ with ISH+), HER2 receptor tyrosine kinase signaling, DNA replication via topoisomerase I, immune effector engagement (NK cell–mediated ADCC). Observational, multicenter, South Korea, endpoints include OS, PFS, and response.