Hepatocellular carcinoma
Conditions
Interventions
TAF group:25 mg TAF orally once daily for 96 weeks after diagnosis.
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-70 years old; 2. HCC was diagnosed as HCC for the first time; 3. Patients undergoing radical surgery for liver cancer (including hepatectomy and ablation); (1) Intraoperative criteria: 1 No tumor thrombus was found in hepatic vein, portal vein, bile duct and inferior vena cava; There was no adjacent organ invasion, no hilar lymph node or distant metastasis; If the margin is less than 1cm, but there is no residual tumor cells in the liver section, that is, the margin is negative; (2) Postoperative judgment criteria: 1 Two months after the operation, ultrasound, CT and MRI (two of them must be included) were performed, and no tumor was found; If AFP increased before operation, AFP should be reduced to normal 2 months after operation; 4. Patients with BCLC stage 0, a or B; 5. Patients with HBV DNA positive (> 20iu / ml); 6. Patients who have not received antiviral treatment; 7. Patients with A-grade child Pugh score; 8. Patients with ECoG score of 0; 9. Informed consent of the patient.
Exclusion criteria
Exclusion criteria: 1. Patients with recurrent hepatocellular carcinoma; 2. Patients with vascular invasion; 3. Patients with a history of cardiovascular disease; 4. Patients with HCV, HIV infection or other severe infections; 5. Patients with other malignant tumors; 6. Patients with mental illness; 7. Patients who have participated in other clinical trials in recent three months; 8. Serious diseases with non malignant tumor will affect patients' compliance or make them in a dangerous state; 9. Patients who have received other immunomodulatory therapy (such as interferon, thymosin, PD-1 or PD-L1 inhibitors, etc.); 10. Previous use of antiviral drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBV DNA inhibition rate;2-year recurrence-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| alanine aminotransferase recurrence rate;Recurrence-free survival, RFS;Overall survival, OS;Incidence of adverse events and serious adverse events; | — |
Countries
China
Contacts
Public ContactXiao Zhiyu
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Outcome results
None listed