Efficacy and Safety of Pegylated Interferon Alpha-2β in Patients With Hepatitis B-related Hepatocellular Carcinoma After Radical Resection

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNingbo No.2 Hospital

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

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