Alternating liver-artery and IV chemotherapy with optional adebrelimab and apatinib for unresectable biliary tract cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Jun Tie, Dr
• Email: tiejun7776@163.com
• Phone: +8618629507963

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• A combination therapy for advanced second-line gastric cancer using apatinib with albumin-bound paclitaxel, with or without adebrelimab

  This study tests whether adding adebrelimab to a regimen of apatinib and albumin-bound paclitaxel helps patients with advanced gastric or gastroesophageal junction cancer who did not respond to first-line therapy.

  Recruiting Phase 2 The First Affiliated Hospital of Zhengzhou University · Zhengzhou, Henan · NCT07770113

• Adebrelimab and apatinib with SOX chemotherapy to make advanced stomach or GE junction cancer operable

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• Adebrelimab with apatinib plus gemcitabine–cisplatin for initially unresectable biliary tract cancer

  This trial tests whether adding the immunotherapy adebrelimab and the targeted drug apatinib to standard chemotherapy helps people with newly diagnosed, unresectable biliary tract cancer.

  Recruiting Phase 2 Tongji Hospital · Wuhan, Hubei · NCT07135544

• Combining Apatinib, Adebrelimab, and Chemotherapy for Advanced Intrahepatic Cholangiocarcinoma

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  Recruiting Phase 2 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou, Guangdong · NCT06925516

• Treatment of advanced biliary tract tumors with HRS-4642 alone or with adebrelimab

  This study is testing if a new treatment called HRS-4642, alone or with another drug called adebrelimab, can help people with advanced biliary tract cancer who haven't had success with other treatments.

  Recruiting Phase 2 Shanghai Zhongshan Hospital · Shanghai, Shanghai Municipality · NCT06620848

• Combining Adebrelimab, Apatinib Mesylate, and Chemotherapy for Treating Limited-stage Small Cell Lung Cancer

  This study is testing a new combination of a drug called adebrelimab, another drug called apatinib mesylate, and chemotherapy to see if it helps people with newly diagnosed limited-stage small cell lung cancer.

  Recruiting Phase 2 Zhejiang Cancer Hospital · Hangzhou, Zhejiang · NCT06483282

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.