HCC
Conditions
Interventions
experimental group:Adebrelimab ( 1200mg, ivgtt, q3w, D1 ) + Apatinib ( 250mg, po, qd ) was given every three weeks as a cycle until the occurrence of an event that met the criteria for termination of
Sponsors
The Third Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Signing informed consent; 2.Aged 18-75 years old; 3.Unresectable HCC confirmed by imaging or histopathological examination based on biopsy specimens and / or surgery; 4.BCLC B-C stage; 5.At least one measurable lesion without local treatment ( RECIST v1.1, mRECIST ); 6.The estimated survival time was = 3 months; 7.Child-Pugh score = 7; 8.ECOG: 0-1; 9.Previous progress has been made in bevacizumab monotherapy / bevacizumab analogues or bevacizumab / bevacizumab analogues combined with PD-1 regimen ( previous systematic treatment regimen = 2 ); 10.Have adequate organ and bone marrow function a) Neutrophil count(ANC)= 1,000/mm^3 (1.0 × 10^9/L); b) Platelet count(PLT) = 75,000/mm^3(75 × 10^9/L); c) Hemoglobin(Hb)= 9 g/dL(90 g/L); d) Serum albumin = 2.8 g/dL; e)Serum creatinine = 1.5 times the upper limit of normal ( ULN ) or creatinine clearance rate = 50 ml / min ; f)Total bilirubin ( TB ) = 2 × ULN, or TB > 2 × ULN but direct bilirubin ( DBil ) = 1.5 × ULN ; g)AST / SGOT or ALT / SGPT levels = 5 × ULN ; 11. Male subjects and women of childbearing age must take contraceptive measures within three months from the beginning of the first dose to the last use of the study drug ; 12.It is expected that the compliance is good and can cooperate with the research according to the requirements of the program ;
Exclusion criteria
Exclusion criteria: 1.Previously received more than two ICIs drug treatment ; 2.Previously received PD-L1 drug treatment ; 3.Subjects have any known active autoimmune diseases ; 4.Subjects are participating in other clinical trials or have received drug intervention in other clinical trials within 4 weeks before the first administration ; 5.Subjects have other malignant tumors that need to be treated ; 6.Subjects had a history of severe cardiovascular disease ; 7.Known uncontrolled or symptomatic active central nervous system ( CNS ) metastasis ; 8.There was a history of hepatic encephalopathy or portosystemic shunt in the past 12 months or the need for drugs to prevent or control encephalopathy ( such as the use of lactulose, rifaximin, etc.for hepatic encephalopathy ) ; 9.Subject serum test HIV positive ; 10. Active hepatitis B ( HbsAg positive and HBV-DNA = 10^3copies / mL ) or active hepatitis C ( HCV antibody positive and HCV-DNA positive, and need antiviral therapy ) ; 11. The presence of allergic or hypersensitivity reactions to monoclonal antibodies ; 12. The researcher believes that diseases or abnormal laboratory indicators that may affect the results of the study, or are not in the interest of the subjects, should be excluded ;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Duration of Response;Disease Control Rate;Overall Survival;Security; | — |
Countries
China
Contacts
Public ContactWeiping Zhou
The Third Affiliated Hospital of Naval Medical University
Outcome results
None listed