RecruitingPhase 2NCT07025174

Sequential Anti-Angiogenic Therapy After Immunotherapy in Advanced Biliary Tract Cancer

Evaluation of the Effect of Sequential Anti-angiogenic Therapy Following Immune Therapy Progression on Survival in Patients With Advanced Biliary Tract Malignancies: A Randomized, Multi-center, Exploratory Clinical Study


Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

60 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using anti-angiogenic drugs (medications that cut off tumor blood supply) after immunotherapy improves outcomes in patients with advanced bile duct or gallbladder cancer (biliary tract cancer) that cannot be removed surgically. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with advanced biliary tract cancer (intrahepatic or extrahepatic bile duct cancer, or gallbladder cancer) confirmed by biopsy - Your cancer cannot be cured with surgery - You have not previously received chemotherapy, immunotherapy, or anti-angiogenic therapy for advanced disease - You are in good health (ECOG 0–1) with a life expectancy of at least 12 weeks - Your blood, liver, and kidney function are adequate **You may NOT be eligible if...** - Your tumor has mixed features including neuroendocrine components - You have active, unstable brain metastases - You have had another cancer in the past 5 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPD-1/CTLA-4 Dual Functional Antibody

PD-1/CTLA-4 Dual Functional Antibody (iparomlimab and tuvonralimab injection): 5 mg/kg intravenous infusion every 3 weeks (day 1 of each 21-day cycle) for up to 6 cycles, with potential for maintenance therapy continuation. Used in combination with GP regimen in experimental arm only. This is a novel dual-functional antibody targeting both PD-1 and CTLA-4 pathways simultaneously.

DRUGGemcitabine, Cisplatin

Gemcitabine 1000 mg/m² d1,8+Cisplatin 25mg/m² d1,8

DRUGAnlotinib

10mg po d1-14 q3w

DRUGOxaliplatin + 5-Fluorouracil/Leucovorin

XELOX (oxaliplatin 130mg/m² d1+capecitabine 1000mg/m² d1-14 q3w) or FOLFOX6 (Oxaliplatin 85 mg/m², leucovorin 400 mg/m², fluorouracil 400 mg/m² intravenous bolus followed by fluorouracil 2400 mg/m² 46 hours, q2w)


Locations(1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT07025174


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