Actively Recruiting
Alternating HAIC and Systemic Chemotherapy With or Without Adebrelimab and Apatinib for Unresectable Biliary Tract Cancer
Led by Air Force Military Medical University, China · Updated on 2026-05-06
124
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Alternating HAIC and Systemic Chemotherapy With or Without Adebrelimab and Apatinib for Unresectable Biliary Tract Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at enrollment
- Confirmed diagnosis of unresectable, locally advanced, or metastatic biliary tract cancer, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer
- No prior systemic therapy for biliary tract cancer, including chemotherapy, immunotherapy, or targeted therapy
- Patients with disease recurrence at least 6 months after curative resection and completion of adjuvant treatment are eligible
- Adequate liver function defined as Child-Pugh Class A (score 5-6) or well-compensated Class B (score 7 or less)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- At least one measurable tumor lesion as defined by RECIST 1.1
- Assessed as able to tolerate and comply with the treatment regimen
- Provided written informed consent voluntarily
You will not qualify if you...
- Hepatic tumor burden occupying 50% or more of total liver volume
- History of liver transplantation
- Major surgery or invasive procedure within 4 weeks before enrollment (except catheter placement or drainage)
- History or evidence of significant bleeding within recent months, including bleeding over 30 mL in past 3 months, hemoptysis over 5 mL in past 4 weeks, or thromboembolic events within past 12 months
- Known active infection with human immunodeficiency virus (HIV)
- Pregnant or breastfeeding women
- Any condition judged by the investigator to compromise patient safety or study outcome assessment, including active substance abuse, severe uncontrolled conditions, significant lab abnormalities, or social/family issues affecting compliance
AI-Screening
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Trial Site Locations
Total: 1 location
1
Air Force Military Medical University
Xi'an, Shaanxi, China, 710032
Actively Recruiting
Research Team
J
Jun Tie, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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