Hepatocellular Carcinoma
Conditions
Interventions
Experimental group:Subjects receive TACE treatment once in the first month after surgery, with tislelizumab 200 mg i.v. q3w (day 1 of each 21-day cycle), and donafenib 200 mg p.o. bid).
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily join the study and sign the informed consent; 2. 18 years old 5 cm and MVI; 5. Child-Pugh Class A; 6. Biochemical indicators of the patient: total bilirubin = 35 g/L, AST, ALT, ALP not higher than 2 times the upper limit of normal value at the time of screening; blood routine: neutrophils >= 1.5 x 10 ^9 /L, Hb >= 85 g/L, PLT >= 75 x 10^9 /L; 7. ECOG performance status score is 0 or 1.
Exclusion criteria
Exclusion criteria: 1. Patients who have received liver transplantation or are on the waiting list for liver transplantation; 2. Patients who have received HCC treatment, including local treatment, targeted drugs, PD1 antibody and other immunotherapy, FOLFOX systemic chemotherapy and other drug treatment; 3. Known fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma or mixed cholangiocarcinoma and hepatocellular carcinoma; 4. Human immunodeficiency virus (HIV) infection, or suffering from autoimmune diseases; 5. Known to have a history of severe allergy to any monoclonal antibody or research drug excipients; 6. Participating in other clinical studies, or the first dose is less than 30 days from the end of the previous clinical study drug treatment; 8. Pregnant or lactating women; 9. According to the investigator's judgment, there are other factors that may affect the research results or cause the study to be terminated midway, such as alcoholism, drug abuse, drug abuse, other serious diseases (including mental diseases) that require combined treatment, and those with severe abnormal laboratory tests, accompanied by family or social factors, will affect the safety of medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Countries
China
Contacts
Public ContactWei Peng
West China Hospital of Sichuan University
Outcome results
None listed