eligibility_summary
Eligibility: 18–75, ECOG 0–1, ≥12‑wk survival, measurable LA/metastatic gastric or GEJ adenocarcinoma after 1st‑line failure/intolerance (not paclitaxel), prior PD‑1/PD‑L1 allowed. HER2/PD‑L1 results, adequate organ/cardiac function. Exclude CNS/leptomeningeal mets, unresolved ≥G2 AEs, recent RT/surgery/vaccine, symptomatic effusion, ≥G2 neuropathy, active HBV/HCV RNA+/HIV, recent serious CV/VTE or bleeding, active infection, uncontrolled illness, other recent cancer, transplant, allergy, pregnancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Randomized, open-label Phase II/III trial in HER2-expressing (IHC 1+/2+/3+) locally advanced/metastatic gastric or GEJ adenocarcinoma after first-line progression. Arms: Disitamab vedotin (DV, RC48) + cadonilimab vs DV vs paclitaxel (Phase II), combo vs paclitaxel (Phase III). Mechanisms/types: Disitamab vedotin is an anti-HER2 antibody–drug conjugate delivering MMAE (microtubule inhibitor) to HER2+ tumor cells, causing mitotic arrest/apoptosis and mediating ADCC. Cadonilimab (AK104) is a bispecific checkpoint inhibitor antibody blocking PD-1 and CTLA-4, enhancing effector T-cell activation and reducing Treg-mediated suppression. Paclitaxel is a cytotoxic microtubule-stabilizing agent. Targets/pathways: HER2 on tumor cells, microtubules, PD-1/PD-L1 and CTLA-4 on T cells.