hepatocellular carcinoma
Conditions
Interventions
Group receiving Peg-IFN-a-2ß combined with NAs treatment after radical resection of liver cancer:Peg-IFN-a-2ß combined with NAs treatment
The group receiving NAs treatment after radical resection of liver cancer:NAs treatment
Sponsors
Ningbo No.2 Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients with HCC confirmed by pathological diagnosis or imaging diagnosis (including enhanced CT or MR); Age: 18 - 65 years old; 2. Patients who have undergone radical surgery must satisfy the following criteria: (1) Preoperative HCC staging must fall within CNLC stage Ia, Ib, or IIa; (2) Radical surgery is defined as either: 1) surgical radical resection performed 4–16 weeks prior, or 2) local treatment primarily based on radiofrequency ablation; (3) Criteria for determining radical surgery: Follow-up examinations via ultrasound, contrast-enhanced CT, or contrast-enhanced MRI of the liver conducted 1–3 months postoperatively must indicate the absence of tumor lesions and no arterial phase hyperenhancement suggestive of viable tumor; (4) In cases with elevated serum AFP levels prior to surgery, AFP must normalize within two months after surgery. 3. Serum HBsAg positive with a level less than 2000 IU/mL; 4. A negative pregnancy test within 24 hours prior to the first dose in the treatment group for women of childbearing potential; and all enrolled patients (both male and female) must employ effective contraceptive methods throughout the study period and for 24 weeks following drug discontinuation; 5. No systemic treatments, including chemotherapy, immunotherapy, or targeted therapy, have been administered prior to enrollment or during the study; 6. Patients and their families must provide informed consent and be willing to comply with follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Patients with recurrent or metastatic liver cancer before treatment; 2. Patients with contraindications to Peg-IFN-a (see "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition)" for details); 3. Peripheral blood picture: WBC 3×ULN, TBIL > 2×ULN; 5. Cirrhosis patients: Child-Pugh score > 5 points; 6. International normalized ratio (INR) of prothrombin > 1.5; 7. Patients planning to receive organ transplantation or who have already undergone organ transplantation; 8. Patients allergic to interferon or with any contraindications listed in the drug instruction manual; 9. Pregnant or lactating women or those planning to become pregnant; 10. Currently participating in other drug clinical trials; 11. Alcohol abuse; 12. Drug abuse; 13. Hereditary or metabolic liver diseases, such as Wilson's disease or hemochromatosis; 14. Concurrent infection with hepatitis A virus, hepatitis C virus, hepatitis E virus, Epstein-Barr virus (EB virus) or cytomegalovirus; 15. Refusal to cooperate with follow-up; 16. Other situations deemed inappropriate for enrollment by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAg level;HBsAg seroconversion rate;HBV DNA levels; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence-free survival ;Overall survival;Th1/Th2 subsets ;intestinal flora; | — |
Countries
China
Contacts
Public ContactLiyun Fu
Ningbo NO.2 Hospital
Outcome results
None listed