eligibility_summary
Adults (≥18) with unresectable/relapsed/metastatic biliary tract cancer (non-ampullary), progressed after ≥1 systemic line (incl. relapse ≤6 months post adjuvant/chemoradiation), no prior PD‑1/PD‑L1/L2 or CTLA‑4 therapy, and ≥1 measurable lesion per RECIST 1.1 (progressed irradiated lesions allowed). Exclude other cancer within 5 years, prior organ/BM transplant, active HBV/HCV above set levels, uncontrolled hypertension, or symptomatic/drainage‑requiring effusions.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Single-arm phase Ib/II trial in advanced biliary tract cancer testing two immune checkpoint inhibitors: IBI310 and sintilimab. IBI310 is an anti-CTLA-4 monoclonal antibody (IgG1) that blocks CTLA-4 on T cells to enhance CD28-mediated costimulation and T-cell priming, its IgG1 Fc may also deplete intratumoral regulatory T cells (Tregs). Sintilimab is an anti–PD-1 monoclonal antibody (IgG4) that blocks PD-1 on activated T cells, preventing PD-L1/PD-L2 inhibitory signaling to reverse T-cell exhaustion and restore cytotoxic activity. Key targets/pathways: CTLA-4/CD80-86 and PD-1/PD-L1 axes, effector CD8+ T cells, helper T cells, and Tregs within the tumor microenvironment.