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

NCT07569679 | Recruiting Phase 2

• 1 other identifier: KY20252547-C-1
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Biliary Tract Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Overall survival (OS) was defined as the time from initiation of study treatment (first dose) to death from any cause.

  The maximum time from receiving treatment to dying for any reason is 3 years.

Secondary Outcomes (3)

• Progression-free Survival (PFS)

  Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 years.

• Objective Response Rate (ORR)

  Every 6 weeks for the first 24 weeks, then every 8 weeks until disease progression or study completion, up to 1 years.

• Disease Control Rate (DCR)

  Every 6 weeks for the first 24 weeks, then every 8 weeks until disease progression or study completion, up to 1 years.

Study Arms (2)

Alternating HAIC and Systemic Chemotherapy Plus Adebrelimab and Apatinib

EXPERIMENTAL

Participants in this arm will receive alternating cycles of HAIC and systemic chemotherapy with gemcitabine plus cisplatin, combined with adebrelimab (1200 mg every 3 weeks) and apatinib (250 mg orally once daily). The dosing and administration of HAIC and systemic chemotherapy follow each center's standard treatment protocols.

Procedure: HAIC; Drug: Gemcitabine plus Cisplatin; Drug: Adebrelimab; Drug: Apatinib

Alternating HAIC and Systemic Chemotherapy Alone

ACTIVE COMPARATOR

Participants in this arm will receive alternating cycles of HAIC and systemic chemotherapy with gemcitabine plus cisplatin. The dosing and administration of HAIC and systemic chemotherapy follow each center's standard treatment protocols.

Procedure: HAIC; Drug: Gemcitabine plus Cisplatin

Interventions

HAIC PROCEDURE

HAIC is administered using a gemcitabine plus cisplatin regimen, with dosing and administration according to each participating center's standard treatment protocols.

Alternating HAIC and Systemic Chemotherapy Alone; Alternating HAIC and Systemic Chemotherapy Plus Adebrelimab and Apatinib

Gemcitabine plus Cisplatin DRUG

Gemcitabine 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.

Alternating HAIC and Systemic Chemotherapy Alone; Alternating HAIC and Systemic Chemotherapy Plus Adebrelimab and Apatinib

Adebrelimab DRUG

Adebrelimab administered intravenously at a dose of 1200 mg every 3 weeks until disease progression or unacceptable toxicity.

Alternating HAIC and Systemic Chemotherapy Plus Adebrelimab and Apatinib

Apatinib DRUG

Apatinib administered orally at a dose of 250 mg once daily until disease progression or unacceptable toxicity.

Alternating HAIC and Systemic Chemotherapy Plus Adebrelimab and Apatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Known active infection with human immunodeficiency virus (HIV).
• Pregnant (a positive pregnancy test prior to study drug administration) or breastfeeding women.
• 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.

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Air Force Military Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Gemcitabine; Cisplatin; apatinib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Jun Tie, Dr

CONTACT

+8618629507963; tiejun7776@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of clinical research

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: May 6, 2026
• Study Start: December 10, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

CN (1)