eligibility_summary
Adults ≥18 with HER2+ (IHC/FISH) unresectable/metastatic BTC adenocarcinoma (gallbladder, intrahepatic, perihilar), ECOG 0–2, adequate organ function, EF ≥50%/normal ECG, measurable disease, ≥12‑wk life expectancy. Prior adjuvant chemo >12 mo, RT ≥3 wks, surgery ≥2 wks. Exclude: distal cholangiocarcinoma, hypersensitivity to study drugs, major cardiac/valvular disease, other active cancer, severe dyspnea, neuropathy >G1, pregnancy/breastfeeding, ILD, prior chemo <1 yr or for metastatic.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT07062263 (TAB-2): Phase III, first-line HER2-positive advanced biliary tract cancer. Interventions: Trastuzumab (humanized monoclonal antibody) + chemotherapy vs chemotherapy alone. Mechanisms: Trastuzumab binds HER2/ERBB2 extracellular domain, inhibits downstream PI3K/AKT and MAPK signaling, promotes receptor internalization, and mediates ADCC. Chemotherapy options: Gemcitabine (antimetabolite nucleoside analog, inhibits ribonucleotide reductase and DNA synthesis), Cisplatin (platinum DNA crosslinker), ± nab-paclitaxel (albumin-bound taxane, stabilizes microtubules causing mitotic arrest). Targets: HER2-overexpressing BTC cells, pathways impacted include HER2/ERBB signaling, DNA replication/repair, and microtubule dynamics, NK-cell mediated ADCC may be engaged. Primary endpoint: 6-month PFS.