Phase
Condition
Liver Cancer
Cancer/tumors
Liver Disorders
Treatment
Anti-PD-1/PD-L1 antibodies
Anti-VEGF
Clinical 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 localtreatment, 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:
The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitialpneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis,nephritis, thyroid Hyperfunction; patients with vitiligo; complete remission ofasthma in childhood, can be included without any intervention after adulthood;asthma patients who require bronchodilators for medical intervention cannot beincluded);
The patient is using immunosuppressive agents or systemic hormonal therapy toachieve immunosuppressive purposes (agents amount > 10 mg / day of prednisone orother therapeutic hormones), and continue to use within 2 weeks before enrollment;
Have clinical symptoms or disease that are not well controlled;
Significant clinically significant bleeding symptoms or a clear bleeding tendencywithin 3 months prior to randomization;
Arterial/venous thrombosis in the first 6 months of randomization
According to the investigator, the patient has other factors that may affect theresults of the study or lead to the termination of the study, such as alcohol abuse,drug abuse, other serious diseases (including mental illness) requiring combinedtreatment, and serious laboratory abnormalities.#with family or social factors, itwill affect the safety of patients.
Liver tumor burden greater than 50% of the total liver volume, or patients who havepreviously undergone liver transplantation;Known for a history of central nervoussystem metastasis or hepatic encephalopathy;Severe allergic reactions to othermonoclonal antibodies;
Study Design
Study Description
Connect with a study center
Zhongshan Hospital Fudan university
Shanghai,
ChinaActive - Recruiting
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