A Phase Ib/II Clinical Study of Camrelizumab and Apatinib Plus GP in the Treatment of Advanced Biliary Tract Cancer

Sponsor
Sun Yat-sen University
Study ID
NCT05742750
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Locally Advanced Biliary Tract Cancer
  • Metastatic Biliary Tract Cancer

Eligibility Criteria

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

Interventions

  • Camrelizumab and Apatinib Plus GP — DRUG
    Patients received apatinib orally at 250 mg once a day irrespective of the patient weight. Camrelizumab 200 mg was administered intravenously over 30 minutes every 3 weeks. GP chemotherapy: Gemcitabine/Cisplatin (gemcitabine 1000mg/m2 + cisplatin 25mg/m2) will be administered on D1/D8 in every three weeks cycle and up to 8 cycles. All patients continued combination treatment until disease progression, unacceptable toxicity, or discontinuation for any reason.

Study Details

The objective of this study is to investigate the safety and tolerability of camrelizumab combined with apatinib and chemotherapies (gemcitabine and cisplatin) in patients with advanced biliary tract cancer (BTC).

Key Dates

First listed
Feb 24, 2023
Start date
Apr 27, 2023
Status verified
Jun 2026
Primary completion
Dec 1, 2025
Completion
May 30, 2026

Study Design

Enrollment
49 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab + apatinib and chemotherapies (gemcitabine and cisplatin)
    Apatinib is a multi-target TKI, which selectively inhibits VEGFR-2. Camrelizumabb is a anti-human PD-1 monoclonal antibody.

Primary Outcome Measure

Incidence of dose-limiting toxicity [ Time Frame: up to day 22 ]

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