A Single-arm, Multicenter, Exploratory Study of Adebrelimab Combined With Apatinib and Systemic Chemotherapy for Initially Unresectable Biliary Tract Cancer

Sponsor
Yongjun Chen
Study ID
NCT07135544
Phase
PHASE2
Status
Recruiting
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Conditions

  • Biliary Tract Cancer
  • Biliary Tract Cancer (CCA)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Adebrelimab combined with the GC regimen and Apatinib — DRUG
    Adebrelimab 1200mg, intravenous infusion, on day 1, repeated every 3 weeks; Gemcitabine 1000mg/m2, on days 1 and 8, every 3 weeks Cisplatin 50mg/m2, on day 1, every 3 weeks Apatinib 250mg, once daily, orally

Study Details

This is an exploratory and prospective study, with the research subjects being patients with initially untreated and unresectable biliary tract tumors. The efficacy and safety of the treatment regimen consisting of Adebrelimab monoclonal antibody combined with targeted therapy and systemic chemotherapy were investigated.

Key Dates

Start date
Aug 14, 2025
Status verified
Aug 2025
Primary completion
Jun 30, 2027
Completion
Dec 30, 2028

Study Design

Enrollment
37 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adebrelimab combined with the GC regimen and Apatinib
    Adebrelimab 1200mg, intravenous infusion, on day 1, repeated every 3 weeks; Gemcitabine 1000mg/m2, on days 1 and 8, every 3 weeks Cisplatin 50mg/m2, on day 1, every 3 weeks Apatinib 250mg, once daily, orally

Primary Outcome Measure

ORR [ Time Frame: At the end of Cycle 6 and 10 (each cycle is 21 days) ]

Central Contacts

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