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

Sponsor
Ningbo No.2 Hospital
Study ID
NCT07553767
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Peginterferon alfa-2b — DRUG
    Peginterferon alfa-2b injection administered subcutaneously
  • TDF — DRUG
    Tenofovir disoproxil fumarate
  • TAF — DRUG
    Tenofovir alafenamide
  • TMF — DRUG
    Tenofovir amibufenamide

Study Details

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

Key Dates

First listed
Apr 28, 2026
Start date
Mar 31, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2034
Completion
Dec 31, 2035

Study Design

Enrollment
156 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Peginterferon alfa-2b combined with NAs
    Patients receive peginterferon alfa-2b (Pegintron®) combined with first-line nucleos(t)ide analogues (TDF/TAF/TMF)
  • Active Comparator: NAs alone
    Patients receive first-line nucleos(t)ide analogues (TDF/TAF/TMF) alone

Primary Outcome Measure

Concentration of Hepatitis B Surface Antigen (Hepatitis B Surface Antigen, HBsAg) [ Time Frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240 ]

Central Contacts

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