Last updated: July 10, 2019
Sponsor: Shanghai Zhongshan Hospital
Overall Status: Active - Recruiting
Phase
2
Condition
Liver Disorders
Liver Cancer
Abdominal Cancer
Treatment
N/AClinical Study ID
NCT04014101
ZSGW-PD-1210
Ages 18-100 All Genders
Study Summary
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
ChinaActive - Recruiting
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