Phase
Condition
Carcinoma
Liver Cancer
Liver Disorders
Treatment
N/AClinical Study ID
Ages 18-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- ≥18 years old, male or female
- Advanced hepatocellular carcinoma (cannot be removed or metastasized) diagnosedclinically or pathologically, at least one measurable lesion without local treatment,Child-Pugh A ;Barcelona Clinic Liver Cancer(BCLC) staging is stage B or C
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Patient has given written informed consent.
- The function of important organs meets the requirements
- Expected survival ≥12 weeks
- Non-surgical sterilization or women of childbearing age need to use amedically-accepted contraceptive (such as an intrauterine device, contraceptive orcondom) during the study period and within 3 months after the end of the studytreatment period.
Exclusion
Exclusion Criteria:
1.The patient has any active autoimmune disease or a history of autoimmune disease (such asthe following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis,enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroid Hyperfunction;patients with vitiligo; complete remission of asthma in childhood, can be included withoutany intervention after adulthood; asthma patients who require bronchodilators for medicalintervention cannot be included); 2.The patient is using immunosuppressive agents orsystemic hormonal therapy to achieve immunosuppressive purposes (agents amount > 10 mg /day of prednisone or other therapeutic hormones), and continue to use within 2 weeks beforeenrollment; 3.Have clinical symptoms or disease that are not well controlled 4.Significantclinically significant bleeding symptoms or a clear bleeding tendency within 3 months priorto randomization 5.Arterial/venous thrombosis in the first 6 months of randomization 6.According to the investigator, the patient has other factors that may affect the resultsof the study or lead to the termination of the study, such as alcohol abuse, drug abuse,other serious diseases (including mental illness) requiring combined treatment, and seriouslaboratory abnormalities.,with family or social factors, it will affect the safety ofpatients.
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
Study Description
Connect with a study center
Zhongshan Hospital, Fudan University
Shanghai, 200032
ChinaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.