Hepatitis B-related Hepatocellular Carcinoma
Conditions
Interventions
Pegylated Interferon a-2b Injection Combined with Nucleoside Analogues Group:Injection of Pegylated Interferon a-2b Combined with Oral administration of Tenofovir Disoproxil Fumarate
Nucleoside Analogues Monotherapy Group:Oral administration of Tenofovir Disoproxil Fumarate
Sponsors
The Third Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 70 years, irrespective of gender. 2. Expected survival of at least 3 months. 3. Positive for Hepatitis B surface antigen (HBsAg). 4. Hepatocellular carcinoma (HCC) confirmed by histopathological examination. 5. Preoperative tumor characteristics must meet the following criteria: Barcelona Clinic Liver Cancer (BCLC) staging of stage 0 or A, solitary tumor. 6. Normal or well-compensated liver function, classified as Child-Pugh grade A. 7. Informed consent must be signed, and the patient must be able to comply with the study requirements; if the patient is unable to give informed consent, a legal guardian or representative must sign on their behalf.
Exclusion criteria
Exclusion criteria: 1. Patients who have undergone any other systemic anti-hepatocellular carcinoma treatments preoperatively, such as liver transplantation, chemoembolization, radiotherapy, chemotherapy, molecular targeted therapy, or biological therapy. 2. Patients currently receiving hepatotoxic drugs or immunosuppressants, or receiving adjuvant chemotherapy postoperatively. 3. Patients with the history of other malignancies, except for cured basal cell or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix. 4. Patients receiving preoperative treatment with interferon. 5. Patients who are allergy to interferon or its components, or deemed unsuitable for interferon therapy by the investigator. 6. Co-infection with HAV, HCV, HDV, HEV, HIV, or having other chronic liver diseases such as alcoholic liver disease, genetic metabolic liver diseases, drug-induced liver diseases. 7. Co-existing autoimmune diseases, including autoimmune liver disease, psoriasis, etc. 8. Severe liver dysfunction or decompensated cirrhosis. 9. Creatinine levels exceeding 1.5 times the upper limit of the normal range. 10. Co-existing severe diseases of vital organs such as heart, lung, kidney, brain, or blood. 11. Patients with severe neurological or psychiatric disorders (e.g., epilepsy, depression, mania, epileptic seizures, schizophrenia). 12. Uncontrolled diabetes, hypertension, thyroid diseases, etc. 13. History of severe retinal lesions or evidence of retinal disease. 14. Substance abuse or alcoholism. 15. Pregnant or breastfeeding women, or those planning to become pregnant or unwilling to use contraception during the study period. 16. Patients who are considered unsuitable for the study due to their current condition, as judged by the researcher. 17. Patients currently participating in other clinical research trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year Disease-free survival Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Recurrence-free survival;Kinetics changes of HBV-DNA;Three-year hepatitis B surface antigen (HBsAg) clearance rate;Kinetics changes of hepatitis B surface antigen (HBsAg) ;Kinetics changes of hepatitis B pre-genomic RNA; | — |
Countries
China
Contacts
Public ContactWeiping Zhou
The Third Affiliated Hospital of Naval Medical University
Outcome results
None listed