drugset / Trial / NCT07569679

Alternating HAIC and Systemic Chemotherapy With or Without Adebrelimab and Apatinib for Unresectable Biliary Tract Cancer

NCT07569679 ↗

Phase 2 Recruiting 124 enrolled Air Force Military Medical University, China
Non-randomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2025-12-10
Primary completion
2028-12-30
Completion
2028-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Adebrelimab Monoclonal antibody 1200 mg Intravenous
Subject Rivoceranib Small molecule 250 mg Oral
Background Cisplatin Other / unclassified — Intravenous
Background Gemcitabine Small molecule — Intravenous

Indications