eligibility_summary
Inclusion: Adults ≥18 with histologically/cytologically confirmed HER2+ advanced gastric or GEJ adenocarcinoma, prior trastuzumab, documented HER2+ (archival or recent pre-2L), initiating monotherapy T-DXd or conventional therapy per SmPC, and provide informed consent. Exclusion: Participation in a still-blinded interventional study, pregnancy or breastfeeding, otherwise per SmPC.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Prospective, non-interventional (real‑world) study in Europe of adults with advanced HER2‑positive gastric/GEJ adenocarcinoma after prior trastuzumab, assessing effectiveness and safety of trastuzumab deruxtecan (T‑DXd, ENHERTU) and registry data on conventional therapies. Drug/interventions and mechanisms: T‑DXd is an antibody–drug conjugate (ADC): trastuzumab (anti‑HER2 IgG1) linked to a cleavable topoisomerase I inhibitor payload (DXd). It binds HER2 (ERBB2), is internalized, releases DXd to poison topo I and induce DNA damage, also blocks HER2 signaling and mediates ADCC, with bystander killing from a membrane‑permeable payload. Conventional regimens: platinum–fluoropyrimidine (DNA crosslinking, thymidylate synthase inhibition), paclitaxel/taxanes (microtubule stabilization), irinotecan (topo I inhibition), ramucirumab (VEGFR‑2 mAb, anti‑angiogenic) ± paclitaxel, and nivolumab/pembrolizumab (PD‑1 inhibitors). Targets/pathways: HER2+ tumor cells, ERBB2 signaling, topoisomerase I, Fc‑mediated ADCC, PD‑1/PD‑L1, VEGFR‑2/angiogenesis, microtubules, DNA synthesis/repair.