Clinical Trial

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

Not Yet Recruiting Early Phase 1
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Summary
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
Trial Details
NCT Number NCT07553767
Lead Sponsor Ningbo No.2 Hospital
Collaborators: Ningbo Medical Center Lihuili Hospital, Ningbo Mingzhou Hospital (Affiliated to Zhejiang University), Shulan (Hangzhou) Hospital
Conditions Hepatocellular Carcinoma, HEPATITIS B CHRONIC, Hepatitis B Chronic Infection
Enrollment 156 participants
Start Date 2026-03-31
Primary Completion 2034-12-31 (estimated)
Study Completion 2035-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-28