eligibility_summary
Adults (≥18) with HER2+ unresectable/metastatic biliary tract adenocarcinoma (cholangiocarcinoma or gallbladder), ECOG 0–1, life expectancy ≥12 wks, measurable disease, progressed after first line, adequate organ/heart function, contraception required. Exclude recent trials/surgery/vaccines/therapy, active infections (HIV, uncontrolled HBV/HCV), uncontrolled illness/autoimmunity, bleeding risk/major effusions, unstable brain mets, high-dose steroids, liver mets ≈≥50%.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Single-arm phase II in China for second-line HER2-mutant/overexpressing advanced or metastatic bile duct adenocarcinoma. Interventions and mechanisms: • Disitamab vedotin (RC48) – antibody-drug conjugate (ADC) against HER2 (ERBB2). After binding HER2 on tumor cells, the ADC is internalized and releases MMAE, a microtubule-disrupting cytotoxin, causing mitotic arrest and apoptosis, also can induce ADCC via Fc. • Cadonilimab (AK104) – tetravalent bispecific immune checkpoint inhibitor antibody targeting PD-1 and CTLA-4, blocking inhibitory signaling to reinvigorate antitumor T-cell activity. Cells/pathways targeted: HER2/ERBB2+ tumor cells and microtubules, PD-1/PD-L1 and CTLA-4 pathways on T cells in the tumor microenvironment.