Exploratory Clinical Study of Apatinib and SHR-1210 in Treating Advanced Hepatocellular Carcinoma or Gastric Cancer

Sponsor
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Study ID
NCT02942329
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • apatinib — DRUG
    Apatinib was administered 250mg or 375mg orally daily. For gastric cancer patients, the dose would be 250mg or 375mg daily. For hepatocellular carcinoma patients, the dose would be 250mg daily.
  • SHR-1210 — DRUG
    SHR-1210 was administered 200mg (3mg/kg for underweight patients) iv every 2 weeks.

Study Details

The purpose of this study is to observe and preliminary explore the efficacy and safety of combination of Apatinib and SHR-1210 regimen in treating advanced hepatocellular carcinoma or gastric cancer. Apatinib is a small-molecule vascular endothelial growth factors receptor (VEGFR) tyrosine kinase inhibitor, similar to vatalanib (PTK787), but with a binding affinity 10 times that of vatalanib or sorafenib. SHR-1210 is a humanized anti-PD-1 monoclonal antibody.

Key Dates

Start date
Oct 31, 2016
Status verified
Jan 2018
Primary completion
Oct 31, 2018
Completion
Oct 31, 2018

Study Design

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

Arms

  • Experimental: apatinib and SHR-1210
    Every patients will received apatinib orally every day and SHR-1210 200mg (3mg/kg for underweight patients) iv every 2 weeks until disease progression or intolerance of side effects.

Primary Outcome Measure

Overall survival rate [ Time Frame: Up to approximately 12 months ]

Central Contacts

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