Alternating HAIC and Systemic Chemotherapy With or Without Adebrelimab and Apatinib for Unresectable Biliary Tract Cancer
A Prospective, Real-World Study of Alternating Hepatic Arterial Infusion Chemotherapy and Systemic Chemotherapy With or Without Adebrelimab and Apatinib in Patients With Unresectable Biliary Tract Cancer
Air Force Military Medical University, China
124 participants
Dec 10, 2025
INTERVENTIONAL
Conditions
Summary
This prospective real-world study aims to evaluate the effectiveness and safety of an alternating treatment regimen combining hepatic arterial infusion chemotherapy (HAIC) with systemic chemotherapy, with or without adebrelimab and apatinib, in patients with unresectable biliary tract cancer receiving first-line treatment. The study comprises two cohorts: one receiving alternating HAIC and systemic chemotherapy alongside adebrelimab and apatinib, and the other receiving alternating HAIC and systemic chemotherapy alone. Treatment allocation follows real-world clinical decision-making. Patients will be monitored throughout the treatment period to assess tumor response, survival outcomes, and safety profiles. The study aims to generate evidence on the clinical benefits of integrating immunotherapy and targeted therapy into HAIC-based regimens for this patient population.
Eligibility
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Interventions
HAIC is administered using a gemcitabine plus cisplatin regimen, with dosing and administration according to each participating center's standard treatment protocols.
Gemcitabine and cisplatin administered intravenously according to institutional standard first-line regimens for biliary tract cancer. Dosing and schedule follow each center's standard treatment protocols.
Adebrelimab administered intravenously at a dose of 1200 mg every 3 weeks until disease progression or unacceptable toxicity.
Apatinib administered orally at a dose of 250 mg once daily until disease progression or unacceptable toxicity.
Locations(1)
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NCT07569679