eligibility_summary
Include: Adults ≥18 with unresectable, first-line advanced/metastatic HER2+ BTC (IHC 2+/3+), peri/adjuvant allowed if >90 d before metastasis, ≤3‑yr FFPE for central testing, ECOG 0–1, adequate organs. Exclude: prior HER2/ADC/ICI/vaccine, ampullary ca, active CNS mets, serious cardiac (recent MI/CHF/QTc), pulmonary (incl ILD), GI/skin or autoimmune disease, active infection, active immunodeficiency/HIV/HCV, other recent cancers, effusions needing drainage, concurrent therapy, prior transplant.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3, first-line HER2-expressing biliary tract cancer. Interventions: 1) Trastuzumab deruxtecan (T-DXd, antibody–drug conjugate): anti-HER2 IgG1 linked to deruxtecan (topoisomerase I inhibitor). Binds HER2 on tumor cells, internalizes, releases cytotoxic payload causing DNA damage with bystander effect. 2) Rilvegostomig (MEDI5752, bispecific checkpoint antibody): targets PD-1 and CTLA-4 to amplify T-cell activation, biasing CTLA-4 blockade to PD-1+ activated T cells. Arms: T-DXd + rilvegostomig or T-DXd alone vs standard-of-care gemcitabine (antimetabolite inhibiting DNA synthesis) + cisplatin (DNA crosslinker) + durvalumab (anti-PD-L1 IgG1). Targets/pathways: HER2/ERBB2 on tumor cells, DNA replication/topoisomerase I, immune checkpoints PD-1/PD-L1 and CTLA-4 on T cells, cytotoxic chemo targets rapidly dividing cells. HER2 and PD-L1 IHC used for biomarker assessment.