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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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 outcome measure(s)
Concentration of Hepatitis B Surface Antigen (Hepatitis B Surface Antigen, HBsAg) — Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240 Serum HBsAg concentration assessed by Chemiluminescent Microparticle Immunoassay (CMIA).
Unit: IU/mL
Proportion of patients with HBsAg loss — Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240 Proportion of patients with HBsAg loss (HBsAg \< 0.05 IU/mL) determined by CMIA. Unit: % of patients
Proportion of patients with HBsAg seroconversion — Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240 Proportion of patients with HBsAg loss (HBsAg \< 0.05 IU/mL) and anti-HBs seropositivity (anti-HBs ≥ 10 mIU/mL) determined by CMIA.
Unit: % of patients
Trial sites (4)
Facility
City
Region
Status
Shulan (Hangzhou) Hospital
Hangzhou
Zhejiang
Ningbo Medical Center Lihuili Hospital
Ningbo
Zhejiang
Ningbo Mingzhou Hospital (Affiliated to Zhejiang University)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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