SHR-1210 Plus Apatinib in Patients With Advanced-Stage Hepatocellular Carcinoma

Sponsor
Shanghai Zhongshan Hospital
Study ID
NCT04014101
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • SHR-1210 — DRUG
    SHR-1210 is a humanized anti-PD-1 IgG4 monoclonal antibody
  • apatinib — DRUG
    Apatinib is a selective VEGFR2 inhibitor.

Study Details

SHR-1210 is a humanized anti-PD-1 Immunoglobulin G4 (IgG4) monoclonal antibody. This is an open- label#single center #non-randomized #Single Arm Exploratory Study . This clinical study is an investigator-initiated clinical trial(IIT) .The objective of this study is to evaluate the efficacy and safety of therapy with anti-PD-1 antibody SHR-1210 and apatinib in patients with advanced stage hepatocellular carcinoma.

Key Dates

Start date
Jun 1, 2019
Status verified
Jul 2019
Primary completion
Oct 1, 2019
Completion
Oct 1, 2020

Study Design

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

Arms

  • Experimental: SHR-1210+ apatinib
    SHR-1210 was administered intravenously (without prophylaxis) at a fixed dose of 200 mg for 3 mg/kg for subjects with a baseline weight \<50 kg. Each infusion for 30 min (not less than 20 min, no more than 60 min), once every 2 weeks, 1 cycle every 4 weeks, the cumulative longest medication period is 2 years; Apatinib was taken orally after meals, once a day, for continuous medication, and 1 cycle every 4 weeks.

Primary Outcome Measure

Objective response rate(ORR) [ Time Frame: 2 years ]

Central Contacts

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