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

Sponsor
First Affiliated Hospital of Zhejiang University
Study ID
NCT07025174
Phase
PHASE2
Status
Recruiting
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Conditions

  • Bile Duct Carcinoma
  • Biliary Tract Cancer
  • Cholangiocarcinoma
  • Gall Bladder Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • PD-1/CTLA-4 Dual Functional Antibody — DRUG
    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.
  • Gemcitabine, Cisplatin — DRUG
    Gemcitabine 1000 mg/m² d1,8+Cisplatin 25mg/m² d1,8
  • Anlotinib — DRUG
    10mg po d1-14 q3w
  • Oxaliplatin + 5-Fluorouracil/Leucovorin — DRUG
    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)

Study Details

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.

Key Dates

First listed
Jun 17, 2025
Start date
Jun 1, 2025
Status verified
May 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard Chemotherapy First-line
    Patients receive standard gemcitabine plus cisplatin (GP) chemotherapy as first-line treatment for up to 6 cycles. Upon disease progression, patients receive second-line treatment with XELOX or FOLFOX chemotherapy plus anlotinib.
  • Experimental: Immunotherapy Plus Chemotherapy First-line
    Patients receive gemcitabine plus cisplatin (GP) chemotherapy combined with PD-1/CTLA-4 dual functional antibody as first-line treatment for up to 6 cycles. Upon disease progression, patients receive the same second-line treatment as the control group with XELOX or FOLFOX chemotherapy plus anlotinib.

Primary Outcome Measure

Progression-Free Survival (PFS) of Second-Line Treatment [ Time Frame: From the start of second-line treatment until disease progression or death from any cause, assessed up to 24 months ]

Central Contacts

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