Alternating liver-artery and IV chemotherapy with optional 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

This study will test whether alternating hepatic arterial infusion chemotherapy and standard IV gemcitabine–cisplatin, with or without the immunotherapy adebrelimab and the targeted drug apatinib, helps people with unresectable biliary tract cancer shrink tumors and live longer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Air Force Military Medical University, China (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, adebrelimab, apatinib
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT07569679 on ClinicalTrials.gov

What this trial studies

This prospective real-world phase 2 study enrolls adults with previously untreated unresectable, locally advanced, or metastatic biliary tract cancer into two cohorts: one receiving alternating HAIC and systemic gemcitabine–cisplatin plus adebrelimab and apatinib, and the other receiving alternating HAIC and systemic chemotherapy alone. Treatment assignment follows routine clinical decision-making rather than randomized allocation. Participants will be monitored for tumor response by RECIST 1.1, progression-free and overall survival, and safety outcomes during treatment and follow-up. The study aims to determine whether integrating PD-L1 blockade and VEGFR2 inhibition into an HAIC-based first-line regimen provides added clinical benefit.

Who should consider this trial

Good fit: Adults (≥18) with histologically or cytologically confirmed unresectable, locally advanced, or metastatic biliary tract cancer who are treatment‑naïve, have at least one measurable lesion, Child‑Pugh A or well‑compensated B (≤7), and ECOG performance status 0–1.

Not a fit: Patients with prior systemic therapy for BTC, poor liver function beyond Child‑Pugh B ≤7, ECOG ≥2, or significant uncontrolled comorbidities are unlikely to be eligible or to benefit from this regimen.

Why it matters

Potential benefit: If successful, adding adebrelimab and apatinib to alternating HAIC and systemic chemotherapy could improve tumor response rates and extend progression-free and overall survival.

How similar studies have performed: Immunotherapy and anti‑angiogenic agents have shown promise in biliary tract cancer and HAIC has demonstrated benefit in liver‑dominant disease, but the specific combination of HAIC with adebrelimab and apatinib is relatively untested in prospective cohorts.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years at the time of enrollment.
2. Histologically or cytologically confirmed diagnosis unresectable, locally advanced, or metastatic BTC, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer.
3. No prior systemic therapy for BTC, including chemotherapy, immunotherapy, or small-molecule targeted therapy.
4. Patients with disease recurrence ≥6 months after curative resection and completion of adjuvant therapy (chemotherapy or radiotherapy) are eligible.
5. Adequate liver function: defined as Child-Pugh Class A (score 5-6) or well-compensated Class B (score ≤7).
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
7. At least one measurable lesion as defined by RECIST 1.1.
8. Assessed by the investigator as being able to tolerate and comply with the study treatment regimen.
9. Provision of written informed consent, voluntarily agreeing to participate after full explanation of the study protocol.

Exclusion Criteria:

1. Hepatic tumor burden occupying ≥50% of total liver volume.
2. History of liver transplantation.
3. Major surgery or invasive procedure (excluding intravenous catheter placement or percutaneous drainage) within 4 weeks prior to enrollment.
4. 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.
5. Known active infection with human immunodeficiency virus (HIV).
6. Pregnant (a positive pregnancy test prior to study drug administration) or breastfeeding women.
7. 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.

Where this trial is running

Xi'an, Shaanxi

• Air Force Military Medical University — Xi'an, Shaanxi, China (Recruiting)

Study contacts

• Study coordinator: Jun Tie, Dr

Conditions Biliary Tract Cancer; First-Line Treatment; HAIC; Adebrelimab; Apatinib