Combine Apatinib Mesylate With PD-1 Antibody SHR-1210 for HCC With High Risk of Recurrence After Radical Resection

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT03839550
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Apatinib Mesylate +SHR-1210 — COMBINATION_PRODUCT
    Apatinib mesylate tablets: 250 mg, orally once a day. Take about half an hour after a meal with warm water (the daily dose should be as much as possible. SHR-1210: 200mg, intravenous infusion for 30 minutes (including the time of the tube, the overall infusion time is not shorter than 20 minutes, no longer than 60 minutes), once every 2 weeks. A total of 6 months of treatment,starting 4-8 weeks after radical hepatic resection.
  • Hepatic Arterial Infusion(HAI) — PROCEDURE
    Twice standard HAI treatment, the first treatment was performed 4-8 weeks after radical hepatic resection, and the second treatment was given 4-8 weeks after the first treatment (the specific time interval depends on the recovery of liver function of the patient). The specific dosage regimen is 80-100 mg of epirubicin or 50 mg of epirubicin + oxaliplatin 50 mg per HAI treatment.

Study Details

The purpose of this study is to assess the efficacy and safety of Apatinib Mesylate combined with PD-1 antibody SHR-1210 in HCC patients with high risk of disease recurrence contained microsatellite lesions, microvascular invasion(MVI) or secondary and above portal vein tumor thrombosis (PVTT) after radical resection. Patients will be randomized 1:1 either to the experimental arm to receive Apatinib Mesylate and PD-1 antibody SHR-1210 or to the standard therapy arm of hepatic arterial infusion(HAI) .

Key Dates

Start date
Feb 15, 2019
Status verified
Feb 2019
Primary completion
Feb 28, 2020
Completion
Feb 28, 2023

Study Design

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

Arms

  • Experimental: Apatinib Mesylate +SHR-1210
    Experimental arm: Apatinib mesylate +PD-1 antibody SHR-1210 for adjuvant therapy of HCC with high incidence of tumor recurrence after hepatic resection
  • Active Comparator: Hepatic Arterial Infusion(HAI)
    Active Comparator arm: HAI for adjuvant therapy of HCC with high incidence of tumor recurrence after hepatic resection

Primary Outcome Measure

Recurrence-free survival(RFS) [ Time Frame: 72 month ]

Central Contacts

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