Apatinib Plus Camrelizumab in Patients With Previously Treated Advanced Biliary Tract Cancer

Sponsor
Peking Union Medical College Hospital
Study ID
NCT04642664
Phase
PHASE2
Status
Completed

Conditions

  • Biliary Tract Cancer
  • Biomarker
  • Cholangiocarcinoma
  • Hepatobiliary Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apatinib plus Camrelizumab — DRUG
    Patients received apatinib orally at 250 mg once a day irrespective of the patient weight. During the treatment, apatinib can reduced to half of piece or once every other day considering the grade of treatment related adverse events. Camrelizumab 200 mg was administered intravenously over 30 minutes every 3 weeks. The intermittent period of camrelizumab was no longer than 6 weeks. All patients continued combination treatment until disease progression, unacceptable toxicity, or discontinuation for any reason.

Study Details

The investigators design a prospective clinical study to explore the efficacy and safety of apatinib plus camrelizumab in pretreated patients with advanced biliary tract malignant tumors and to analyze potential biomarkers of therapeutic response.

Key Dates

Start date
Dec 1, 2018
Status verified
Nov 2020
Primary completion
Dec 1, 2020
Completion
Jan 1, 2021

Study Design

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

Arms

  • Experimental: Apatinib plus Camrelizumab
    Apatinib is a multi-target TKI, which selectively inhibits VEGFR-2. Camrelizumabb is a anti-human PD-1 monoclonal antibody.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Six months ]

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