About this trial
The goal of this clinical trial is to evaluate the efficacy and safety of peginterferon alfa-2β (Peg-IFN-α-2β) combined with nucleos(t)ide analogues (NAs) in patients aged 18 to 65 years with hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) after radical resection. The main questions it aims to answer are:
* What are the changes in hepatitis B surface antigen (HBsAg) disappearance rate, HBsAg seroconversion rate, HBsAg decline, and hepatitis B virus deoxyribonucleic acid (HBV DNA) levels during treatment and at the end of treatment? * What are the 1-year, 2-year, 3-year, and 5-year recurrence-free survival (RFS) and overall survival (OS) of the included patients? * What are the correlations between changes in HBsAg, T helper 1/T helper 2 (Th1/Th2) subsets, intestinal flora and RFS, OS in these patients?
Researchers will compare Peg-IFN-α-2β combined with NAs to NAs alone to see if the combination treatment can improve HBsAg clearance, seroconversion, long-term survival and reduce recurrence in patients after radical resection of hepatitis B-related hepatocellular carcinoma.
Participants will:
* Receive either Peg-IFN-α-2β combined with first-line NAs (tenofovir disoproxil fumarate \[TDF\], tenofovir alafenamide fumarate \[TAF\], tenofovir amibufen fumarate \[TMF\]) or first-line NAs alone * Undergo regular assessments including HBsAg, HBV DNA, liver and renal function, blood routine, thyroid function, autoantibodies, and tumor markers * Provide stool samples for intestinal flora analysis at specified time points * Complete long-term survival follow-up for up to 5 years
Eligibility criteria
Qualifiers
Age 18 to 65 years, male or female.
Confirmed diagnosis of hepatitis B virus-related hepatocellular carcinoma (HCC) by pathology or contrast-enhanced CT/MRI.
Underwent radical resection or local ablation therapy; CNLC (Chinese Liver Cancer Classification) stage Ia, Ib, or IIa; no residual tumor confirmed by imaging within 1-3 months postoperation.
HBsAg positive and HBsAg level < 2000 IU/mL.
Disqualifiers
Recurrent or metastatic HCC at enrollment.
Contraindication to peginterferon alfa-2b treatment.
WBC < 3.5×10⁹/L or platelet count < 100×10⁹/L.
ALT > 3×ULN or total bilirubin (TBIL) > 2×ULN.
Trial design
Treatments tested in this trial
- Peginterferon alfa-2b
- TDF
- TAF
- TMF
Treatment groups
Sponsors and collaborators
Ningbo No.2 Hospital
Lead sponsor
Ningbo Medical Center Lihuili Hospital
Collaborator
Ningbo Mingzhou Hospital (Affiliated to Zhejiang University)
Collaborator
Shulan (Hangzhou) Hospital
Collaborator