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

Last updated: July 10, 2019
Sponsor: Shanghai Zhongshan Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Liver Disorders

Liver Cancer

Abdominal Cancer

Treatment

N/A

Clinical Study ID

NCT04014101
ZSGW-PD-1210
  • Ages 18-100
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 1.≥18 years old, male or female 2.Advanced liver cancer (cannot be removed ormetastasized) diagnosed clinically or pathologically, at least one measurable lesionwithout local treatment, Child-Pugh A ;Barcelona Clinic Liver Cancer(BCLC) staging isstage B or C 3.Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 4.Patient has given written informed consent. 5.Previous treatment failure withsorafenib or rivastatin (disease of disease or toxicity) or unwillingness to accept,economically unsustainable sorafenib treatment; 6.The function of important organsmeets the requirements 7.Expected survival ≥12 weeks 8.Non-surgical sterilization orwomen of childbearing age need to use a medically-accepted contraceptive (such as anintrauterine device, contraceptive or condom) during the study period and within 3months after the end of the study treatment period; non-surgical sterilization Femalepatients of childbearing age must have a negative serum or urine human chorionicgonadotropin(HCG) test within 72 hours prior to study enrollment; and must benon-lactating; for male patients with maternal age, they should be given SHR-1210during the trial and after the last 3 effective methods of contraception within amonth.

Exclusion

Exclusion Criteria:

  • 1.The patient has any active autoimmune disease or a history of autoimmune disease (suchas the following, but not limited to: autoimmune hepatitis, interstitial pneumonia,uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroidHyperfunction; patients with vitiligo; complete remission of asthma in childhood, can beincluded without any intervention after adulthood; asthma patients who requirebronchodilators for medical intervention cannot be included); 2.The patient is usingimmunosuppressive agents or systemic hormonal therapy to achieve immunosuppressive purposes (agents amount > 10 mg / day of prednisone or other therapeutic hormones), and continue touse within 2 weeks before enrollment; 3.Have clinical symptoms or disease that are not wellcontrolled 4.Significant clinically significant bleeding symptoms or a clear bleedingtendency within 3 months prior to randomization 5.Arterial/venous thrombosis in the first 6months of randomization 6.According to the investigator, the patient has other factors thatmay affect the results of the study or lead to the termination of the study, such asalcohol abuse, drug abuse, other serious diseases (including mental illness) requiringcombined treatment, and serious laboratory abnormalities.,with family or social factors, itwill affect the safety of patients.

7.Liver tumor burden greater than 50% of the total liver volume, or patients who havepreviously undergone liver transplantation;Known for a history of central nervous systemmetastasis or hepatic encephalopathy;Severe allergic reactions to other monoclonalantibodies;

Study Design

Total Participants: 40
Study Start date:
June 01, 2019
Estimated Completion Date:
October 01, 2020

Connect with a study center

  • Zhongshan Hospital

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

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