hepatocellular carcinoma
Conditions
Interventions
None:No intervention.
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed informed consent. Aged 18 to 75 years; 2. Locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC). Confirmation either by histologic confirmation or accepted radiographic criteria; 3. Child Pugh A or B(<=7 points), ECOG performance status of 0 to 1; 4. HBV-DNA<103IU/ml.HCV-RNA is lowest limit of detection; 5. Adequate hematologic and end-organ function.
Exclusion criteria
Exclusion criteria: 1. History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death.Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC. 2. Prior organ allograft such as liver transplant, etc. or allogeneic bone marrow transplantation; 3. Active or history of autoimmune disease or immune deficiency; 4. Patients must not have a history of severe allergic reactions (i.e., grade 4 allergy, anaphylactic reaction from which the subject did not recover within 6 hours of institution of supportive care) to any unknown allergens or any components of the immune checkpoint inhibitors; 5. Local therapy to liver within 28 days prior to initiation of study treatment(prior treatment with anti-PD1 or anti-PD-L1 antibody therapy). Medical condition that requires chronic systemic steroid therapy, or any other form of immunosuppressive medication; 6. Contraindications of Liver biopsy; 7. A prior bleeding event due to esophageal and/or gastric varices. Active ongoing infection requiring therapy; 8. Cardiac conditions: class 3-4 New York Heart Association congestive heart failure, known baseline LVEF < 50%, transmural myocardial infarction, uncontrolled hypertension, angina pectoris requiring medication, clinically significant valvular disease, high-risk arrhythmia in the past 12 months; 9. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation and in the judgment of the investigator would make the patient inappropriate for entry into this study; 10. Pregnancy or breastfeeding, or planning to become pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;objective response rate; | — |
Countries
China
Contacts
Public ContactTongchun Xue
Zhongshan Hospital, Fudan University
Outcome results
None listed