Actively Recruiting
Sequential Anti-Angiogenic Therapy After Immunotherapy in Advanced Biliary Tract Cancer
Led by First Affiliated Hospital of Zhejiang University · Updated on 2025-06-17
60
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Brief Summary: This study is for patients with advanced biliary tract cancer (cancer of the bile ducts or gallbladder). The purpose is to find out if using anti-blood vessel formation drugs after immunotherapy treatment can help patients live longer without their cancer getting worse. What the study compares: Control group: Patients receive standard chemotherapy as first-line treatment, then chemotherapy plus anlotinib (an anti-blood vessel drug) if their cancer progresses Treatment group: Patients receive chemotherapy plus immunotherapy as first-line treatment, then the same second-line treatment as the control group if their cancer progresses Who can join: Patients aged 18-75 with advanced biliary tract cancer that has been confirmed by tissue testing, who have not received immunotherapy or anti-blood vessel drugs before, and who are in good enough health for treatment. What we want to learn: The main goal is to see if patients who received immunotherapy first have better outcomes when they later receive anti-blood vessel treatment. We will measure how long patients live without their cancer getting worse during second-line treatment. Study design: This is a randomized study, meaning patients are assigned by chance to one of the two treatment groups. About 60 patients will participate across multiple hospitals in China. We will also collect blood and tissue samples to better understand how these treatments work. The study will help doctors determine if this treatment sequence could become a new standard approach for patients with advanced biliary tract cancer.
CONDITIONS
Official Title
Sequential Anti-Angiogenic Therapy After Immunotherapy in Advanced Biliary Tract Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years at enrollment
- Confirmed advanced or metastatic biliary tract adenocarcinoma by tissue test
- Unresectable locally advanced or metastatic disease not suitable for curative treatment
- At least one measurable tumor lesion per RECIST 1.1 criteria
- ECOG Performance Status 0 or 1
- Life expectancy of at least 12 weeks
- No prior systemic chemotherapy, immunotherapy, or anti-angiogenic therapy for advanced disease (adjuvant therapy completed over 6 months ago allowed)
- Adequate bone marrow function: ANC ≥ 1.5×10⁹/L, platelets ≥ 100×10⁹/L, hemoglobin ≥ 90 g/L
- Adequate liver function: Total bilirubin ≤ 2.5× upper limit normal, ALT and AST ≤ 3× upper limit normal (or ≤ 5× if liver metastases present)
- Adequate kidney function: Serum creatinine ≤ 1.5× upper limit normal or creatinine clearance ≥ 50 mL/min
- Signed informed consent
You will not qualify if you...
- Tumors with mixed histology or neuroendocrine components
- Active central nervous system metastases (treated and stable metastases over 4 weeks allowed)
- History of other cancers within 5 years except certain treated skin cancers or carcinoma in situ
- Active autoimmune disease requiring systemic treatment
- Severe allergic reactions to monoclonal antibodies or study drugs
- Uncontrolled high blood pressure (>140/90 mmHg despite medication)
- Significant heart disease including recent myocardial infarction or severe heart failure
- Active bleeding, bleeding tendency, thrombosis, or current use of blood thinners
- Recent major surgery within 4 weeks or minor surgery within 2 weeks
- Active infection needing systemic treatment
- Pregnancy or breastfeeding
- HIV infection or active hepatitis B or C
- Psychiatric illness limiting study compliance
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
Z
Zhen Liu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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