A Study of Adebrelimab in Combination With Apatinib Gemcitabine and Cisplatin in Biliary Tract Malignancies

Sponsor
First Affiliated Hospital of Fujian Medical University
Study ID
NCT06181032
Phase
PHASE1
Status
Recruiting
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Conditions

  • Biliary Tract Malignancies

Eligibility Criteria

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

Interventions

  • Adebrelimab — DRUG
    Adebrelimab: 1200mg or 20mg/kg, iv, D1, Q3W;
  • Apatinib — DRUG
    Apatinib: 250 mg, po, QD, Q3W;
  • Gemcitabine — DRUG
    Gemcitabine: 1000 mg/m2, iv, 30min, D1, D8, Q3W;
  • Cisplatin — DRUG
    Cisplatin: 25 mg/m2, iv, 30min, D1, D8, Q3W; Injection sequence: adebelizumab → gemcitabine → cisplatin (sequential interval of at least 30 min), 3 cycles of neoadjuvant therapy.

Study Details

Evaluating the efficacy and safety of adebrelimab in combination with apatinib, gemcitabine and cisplatin in the neoadjuvant treatment of patients with biliary tract malignancies.

Key Dates

Start date
Dec 23, 2023
Status verified
Apr 2024
Primary completion
Feb 23, 2029
Completion
Feb 23, 2029

Study Design

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

Arms

  • Experimental: Single arm
    Neoadjuvant treatment with adebrelimab in combination with apatinib gemcitabine and cisplatin

Primary Outcome Measure

Relapse free survival（RFS） [ Time Frame: 3 years ]

Central Contacts