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.
Age ≥ 18 years at the time of enrollment.
Histologically or cytologically confirmed diagnosis unresectable, locally advanced, or metastatic BTC, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer.
No prior systemic therapy for BTC, including chemotherapy, immunotherapy, or small-molecule targeted therapy.
Patients with disease recurrence ≥6 months after curative resection and completion of adjuvant therapy (chemotherapy or radiotherapy) are eligible.
Hepatic tumor burden occupying ≥50% of total liver volume.
History of liver transplantation.
Major surgery or invasive procedure (excluding intravenous catheter placement or percutaneous drainage) within 4 weeks prior to enrollment.
History or evidence of clinically significant bleeding, including: bleeding >30 mL within 3 months prior to enrollment (including hematemesis, melena, or hematochezia), hemoptysis (>5 mL of fresh blood) within 4 weeks prior to enrollment, or thromboembolic events (including stroke or transient ischemic attack) within the past 12 months.
Parallel
HAIC
Procedure/SurgeryHAIC is administered using a gemcitabine plus cisplatin regimen, with dosing and administration according to each participating center's standard treatment protocols.
Gemcitabine plus Cisplatin
DrugGemcitabine 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
DrugAdebrelimab administered intravenously at a dose of 1200 mg every 3 weeks until disease progression or unacceptable toxicity.
Apatinib
DrugApatinib administered orally at a dose of 250 mg once daily until disease progression or unacceptable toxicity.
Overall Survival (OS)
Overall survival (OS) was defined as the time from initiation of study treatment (first dose) to death from any cause.
Progression-free Survival (PFS)
Progression-free survival (PFS), assessed by investigators per RECIST version 1.1, was defined as the time from initiation of study treatment (first dose) to the first documentation of objective disease progression or death from any cause, which ever occurred first.
Objective Response Rate (ORR)
Disease assessments based on investigator assessments were determined by using RECIST version 1.1 guidelines. The ORR was defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR). The CR was defined as disappearance of all target and non-target lesions and no new lesions. The PR was defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion.
Disease Control Rate (DCR)
Disease control rate based on investigator assessments according to RECIST version 1.1 was defined as the rate of best objective response of complete response (CR), partial response (PR) or stable disease (SD).
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