Anti-blood-vessel therapy after immunotherapy for advanced bile duct or gallbladder 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 randomized Phase 2 trial enrolls adults 18–75 with histologically confirmed unresectable or metastatic biliary tract adenocarcinoma and ECOG performance status 0–1. Participants are assigned to receive either standard gemcitabine/cisplatin chemotherapy as first-line therapy or gemcitabine/cisplatin combined with a PD-1/CTLA-4 dual functional antibody as first-line therapy; patients in both arms receive the same second-line options including anlotinib if disease progresses. The primary endpoint is progression-free survival, with secondary endpoints including overall survival, response rate, and safety. The trial is conducted at a single center in Hangzhou, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Age 18-75 years at time of enrollment; Histologically or cytologically confirmed advanced or metastatic biliary tract adenocarcinoma (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder carcinoma); Unresectable locally advanced or metastatic disease not amenable to curative treatment; At least one measurable lesion according to RECIST version 1.1 criteria; ECOG Performance Status 0-1; Life expectancy ≥ 12 weeks; No prior systemic chemotherapy, immunotherapy, or anti-angiogenic therapy for advanced disease (adjuvant therapy completed \>6 months prior is 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×ULN, ALT and AST ≤3×ULN (or ≤5×ULN if liver metastases present); Adequate renal function: Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min; Signed informed consent.

Exclusion Criteria:

Mixed histology tumors or neuroendocrine components; Active central nervous system metastases (treated and stable metastases \>4 weeks allowed); History of other malignancies within 5 years (except adequately treated basal cell carcinoma, squamous cell carcinoma of skin, or carcinoma in situ); Active autoimmune disease requiring systemic treatment; History of severe allergic reactions to monoclonal antibodies or study drug components; Uncontrolled hypertension (\>140/90 mmHg despite medication); Significant cardiovascular disease including unstable angina, myocardial infarction within 6 months, or NYHA Class III-IV heart failure; Active bleeding or bleeding tendency, thrombosis, or use of anticoagulants; Major surgery within 4 weeks or minor surgery within 2 weeks; Active infection requiring systemic treatment; Pregnancy or breastfeeding; HIV infection, active hepatitis B or C infection; Psychiatric illness that would limit compliance with study requirements.

Where it's running

• The First Affiliated Hospital, Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Tingbo Liang, MD — Department of Hepatobiliary and Pancreatic Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine
• Study coordinator: Zhen Liu, MD
• Email: liuzhen@cancer.ac.cn
• Phone: 86-571-87235407

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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.