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ClinicalTrials.gov ID

NCT07553767

Lead Sponsor

Ningbo No.2 HospitalOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Early Phase 1

Enrollment

156Estimated

Last Update Posted

Apr 28, 2026Actual

Start Date

Mar 31, 2026Estimated

Primary Completion Date

Dec 31, 2034Estimated

Completion Date

Dec 31, 2035Estimated

Official Title

A Non-randomized Controlled, Prospective, Real-world Study to Evaluate the Efficacy and Safety of Pegylated Interferon Alpha-2β in Patients With Hepatitis B-related Hepatocellular Carcinoma After Radical Resection

Brief 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

• Hepatocellular Carcinoma
• HEPATITIS B CHRONIC
• Hepatitis B Chronic Infection

• Peginterferon alfa-2b
• TDF
• TAF
• TMF

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• 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.
• No prior systemic chemotherapy, immunotherapy, or targeted therapy before enrollment.
• Able to provide written informed consent and comply with the follow-up schedule.
• For women of childbearing potential: negative pregnancy test and effective contraception during treatment and for 24 weeks after the last dose.

Exclusion Criteria:

• 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.
• Child-Pugh score > 5 points.
• INR > 1.5.
• History of organ transplantation or planned transplantation.
• Hypersensitivity to peginterferon alfa-2b or any excipient of the study drug.
• Pregnant or breastfeeding women.
• Participation in another interventional clinical trial.
• History of significant alcoholism or drug abuse.
• Genetic or metabolic liver disease (Wilson disease, hemochromatosis, etc.).
• Coinfection with HAV, HCV, HEV, EBV, CMV , or other viral hepatitis that may interfere with study evaluation.
• Unable to comply with study procedures and follow-up.
• Other conditions deemed inappropriate by the investigator.

Primary Purpose

Treatment

Allocation

Non-Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Ningbo No.2 HospitalOTHER

Collaborators

Ningbo Medical Center Lihuili HospitalOTHER_GOV

Ningbo Mingzhou Hospital (Affiliated to Zhejiang University)UNKNOWN

Shulan (Hangzhou) HospitalOTHER

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