NCT07569679RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 124 (estimated)
- First submitted
- 4 Dec 2025
- Start date
- 10 Dec 2025
- Primary completion date
- 30 Dec 2028
- Lead sponsor
- Air Force Military Medical University, China
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07569679
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 124
- From 10 Dec 2025 to the primary completion date, 30 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Pregnant (a positive pregnancy test prior to study drug administration) or breastfeeding women.
Other illness
- History of liver transplantation.
- Known active infection with human immunodeficiency virus (HIV).
Lab values
- Any condition, in the investigator's judgment, that could compromise patient satety, affect the assessment of study outcomes, or lead to premature discontinuation. this includes, but is not limited to: active alcohol or substance abuse, severe uncontrolled comorbidities, significant laboratory abnormalities, or social/family circumstances that could interfere with protocol compliance.
Other
- Hepatic tumor burden occupying ≥50% of total liver volume.
Who the study is looking for
- 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.
- Adequate liver function: defined as Child-Pugh Class A (score 5-6) or well-compensated Class B (score ≤7).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- At least one measurable lesion as defined by RECIST 1.1.
- Assessed by the investigator as being able to tolerate and comply with the study treatment regimen.
- Provision of written informed consent, voluntarily agreeing to participate after full explanation of the study protocol.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Air Force Military Medical University Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.