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

156 Participants
are divided into 2 treatment groups

Locations

4
Shulan (Hangzhou) Hospital310022, HangzhouZhejiang, China
Ningbo Medical Center Lihuili Hospital315000, NingboZhejiang, China
Ningbo Mingzhou Hospital (Affiliated to Zhejiang University)315000, NingboZhejiang, China
Ningbo No.2 Hospital315000, NingboZhejiang, China

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