SHR-1210 Plus Apatinib in Patients With Hepatocellular Carcinoma After Surgery

Sponsor
Shanghai Zhongshan Hospital
Study ID
NCT03722875
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • SHR-1210 — DRUG
    SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.
  • apatinib — DRUG
    Apatinib is a selective VEGFR2 inhibitor

Study Details

SHR-1210 is a humanized anti-PD1 Immunoglobulin G4 (IgG4) monoclonal antibody. This is an open- label，single center ，non-randomized ，Single Arm Exploratory Study . This clinical study is an investigator-initiatedclini-cal trial（IIT ）.The objective of this study is to evaluate the efficacy and safety of adjuvant therapy with anti-PD-1 antibody SHR-1210 and apatinib in patients with Barcelona Clinic Liver Cancer (BCLC) B\&C stage hepatocellular carcinoma after surgery.

Key Dates

Start date
Dec 1, 2018
Status verified
Oct 2018
Primary completion
Mar 1, 2019
Completion
Mar 1, 2020

Study Design

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

Arms

  • Experimental: SHR-1210+ apatinib
    SHR-1210 (200mg fixed dose every 3 weeks, one cycle is three weeks, total 1 year ) will be administered as an intravenous infusion over 30 minutes. apatinib 250 mg qd ， one cycle is three weeks, total 1 year

Primary Outcome Measure

relapse-free survival(RFS) [ Time Frame: 1 year ]

Central Contacts

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