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NCT Number: NCT07553767

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

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

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Blood-Borne Infections Carcinoma Carcinoma, Hepatocellular Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Disease Attributes HEPATITIS B CHRONIC Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B Chronic Infection Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Shulan (Hangzhou) Hospital, Hangzhou, Zhejiang, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peginterferon alfa-2b

Drug

Peginterferon alfa-2b injection administered subcutaneously

TDF

Drug

Tenofovir disoproxil fumarate

TAF

Drug

Tenofovir alafenamide

TMF

Drug

Tenofovir amibufenamide

Primary outcomes

  1. 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

    Serum HBsAg concentration assessed by Chemiluminescent Microparticle Immunoassay (CMIA).

    Unit: IU/mL

  2. Proportion of patients with HBsAg loss

    Time frame: 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

  3. Proportion of patients with HBsAg seroconversion

    Time frame: 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

Secondary outcomes

  1. Concentration of HBV DNA (Hepatitis B Virus Deoxyribonucleic Acid)

    Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240

    Serum HBV DNA viral load quantified by a TaqMan-based real-time quantitative polymerase chain reaction (qPCR) assay.

    Unit: IU/mL

  2. Concentration of Hepatitis B e Antigen (HBeAg)

    Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240

    Serum HBeAg concentration assessed by CMIA. Unit: S/CO

  3. Composition and diversity of intestinal microbiota

    Time frame: Baseline, Week 24, Week 48

    Intestinal microbiota analyzed by 16S rRNA gene high-throughput sequencing. Unit: Relative abundance (%) and alpha diversity index

  4. Recurrence-Free Survival (RFS)

    Time frame: Years 1, 2, 3, 5

    Time to first hepatocellular carcinoma (HCC) recurrence or death from any cause, which is confirmed by contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI).

    Unit: Months

  5. Overall survival (OS)

    Time frame: Years 1, 2, 3, 5

    Time from enrollment to death from any cause, regardless of the cause of death. Unit: Months

  6. Concentration of Interleukin-2 (IL-2)

    Time frame: Baseline, Week 24, Week 48

    Serum levels of IL-2 will be measured using cytometric bead array (CBA). Unit: pg/mL

  7. Concentration of Interleukin-4 (IL-4)

    Time frame: Baseline, Week 24, Week 48

    Serum levels of IL-4 will be measured using cytometric bead array (CBA). Unit: pg/mL

  8. Concentration of Interleukin-6 (IL-6)

    Time frame: Baseline, Week 24, Week 48

    Serum levels of IL-6 will be measured using cytometric bead array (CBA). Unit: pg/mL

  9. Concentration of Interleukin-10 (IL-10)

    Time frame: Baseline, Week 24, Week 48

    Serum levels of IL-10 will be measured using cytometric bead array (CBA). Unit: pg/mL

  10. Concentration of Tumor Necrosis Factor-α (TNF-α)

    Time frame: Baseline, Week 24, Week 48

    Serum levels of TNF-α will be measured using cytometric bead array (CBA). Unit: pg/mL

  11. Concentration of Interferon-γ (IFN-γ)

    Time frame: Baseline, Week 24, Week 48

    Serum levels of IFN-γ will be measured using cytometric bead array (CBA). Unit: pg/mL

Other outcomes

  1. The Levels of Thyroid Stimulating Hormone (TSH)

    Time frame: Baseline, Weeks 12, 24, 36, 48

    TSH measured by chemiluminescent immunoassay (CLIA). Unit: mIU/L

  2. The Levels of Free Triiodothyronine (FT3)

    Time frame: Baseline, Weeks 12, 24, 36, 48

    FT3 measured by chemiluminescent immunoassay (CLIA). Unit: pmol/L

  3. The Levels of Free Thyroxine (FT4)

    Time frame: Baseline, Weeks 12, 24, 36, 48

    FT4 measured by chemiluminescent immunoassay (CLIA). Unit: pmol/L

  4. The Levels of Thyroglobulin Antibody (TgAb)

    Time frame: Baseline, Weeks 12, 24, 36, 48

    TgAb measured by chemiluminescent immunoassay (CLIA). Unit: IU/mL

  5. The Levels of Thyroid Peroxidase Antibody (TPOAb)

    Time frame: Baseline, Weeks 12, 24, 36, 48

    TPOAb measured by chemiluminescent immunoassay (CLIA). Unit: IU/mL

  6. Concentration of Alpha-fetoprotein (AFP)

    Time frame: Baseline, Weeks 12, 24, 36, 48, 96, 144, 192

    AFP measured by CLIA. Unit: ng/mL

  7. Serum levels of Protein induced by vitamin K absence-II (PIVKA-II)

    Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240

    PIVKA-II measured by chemiluminescence immunoassay (CLIA). Unit: mAU/mL

  8. Levels of Red Blood Cell count (RBC)

    Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240

    RBC measured by automated hematology analyzer. Unit: ×10¹²/L

  9. Levels of White Blood Cell (WBC)

    Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240

    WBC measured by automated hematology analyzer. Unit: ×10⁹/L

  10. Levels of Platelet (PLT)

    Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240

    PLT measured by automated hematology analyzer. Unit: ×10⁹/L

  11. Levels of Absolute Neutrophil Count (ANC)

    Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240

    ANC measured by automated hematology analyzer. Unit: ×10⁹/L

  12. Levels of Absolute Lymphocyte Count (ALC)

    Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240

    ALC measured by automated hematology analyzer. Unit: ×10⁹/L

  13. Levels of Absolute Monocyte Count (AMC)

    Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240

    AMC measured by automated hematology analyzer. Unit: ×10⁹/L

  14. Levels of Hemoglobin (Hb)

    Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240

    Hb measured by automated hematology analyzer. Unit: g/L

  15. Serum Levels of Alanine Aminotransferase (ALT)

    Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240

    ALT measured by automated biochemical analyzer. Unit: IU/L

  16. Serum Levels of Aspartate Aminotransferase (AST)

    Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240

    AST measured by automated biochemical analyzer. Unit: IU/L

  17. Serum Levels of Alkaline Phosphatase (ALP)

    Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240

    ALP measured by automated biochemical analyzer. Unit: IU/L

  18. Serum Levels of Gamma-Glutamyl Transferase (GGT)

    Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240

    GGT measured by automated biochemical analyzer. Unit: IU/L

  19. Serum Levels of Total Bilirubin (TBil)

    Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240

    TBil measured by automated biochemical analyzer. Unit: μmol/L

  20. Serum Levels of Direct Bilirubin (DBil)

    Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240

    DBil measured by automated biochemical analyzer. Unit: μmol/L

  21. Serum Levels of Indirect Bilirubin (IBil)

    Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240

    IBil measured by automated biochemical analyzer. Unit: μmol/L

  22. Serum Levels of Alpha-L-Fucosidase (AFU)

    Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240

    AFU measured by automated biochemical analyzer. Unit: U/L

  23. Serum Levels of Albumin (ALB)

    Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240

    ALB measured by automated biochemical analyzer. Unit: g/L

  24. Levels of Estimated Glomerular Filtration Rate (eGFR)

    Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240

    eGFR measured by automated biochemical analyzer. Unit: ml/min

  25. Serum Levels of Creatinine (Cr)

    Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240

    Cr measured by automated biochemical analyzer. Unit: μmol/L

  26. The Levels of Antinuclear Antibody (ANA)

    Time frame: Baseline, Weeks 12, 24, 36, 48

    ANA detected by indirect immunofluorescence assay (IFA). Unit: Positive or Negative; Titer

  27. The Levels of Antimitochondrial Antibody (AMA)

    Time frame: Baseline, Weeks 12, 24, 36, 48

    AMA detected by indirect immunofluorescence assay (IFA). Unit: Positive or Negative; Titer

  28. The Levels of Smooth Muscle Antibody (SMA)

    Time frame: Baseline, Weeks 12, 24, 36, 48

    SMA detected by indirect immunofluorescence assay (IFA). Unit: Positive or Negative; Titer

  29. The Levels of Anti-Liver-Kidney Microsomal Antibody 1 (Anti-LKM1)

    Time frame: Baseline, Weeks 12, 24, 36, 48

    Anti-LKM1 detected by indirect immunofluorescence assay (IFA). Unit: Positive or Negative; Titer

  30. The Levels of Anti-Soluble Liver Antigen / Liver-Pancreas Antigen (Anti-SLA/LP)

    Time frame: Baseline, Weeks 12, 24, 36, 48

    Anti-SLA/LP detected by indirect immunofluorescence assay (IFA). Unit: Positive or Negative; Titer

  31. The Levels of Anti-Neutrophil Cytoplasmic Antibody (ANCA)

    Time frame: Baseline, Weeks 12, 24, 36, 48

    ANCA detected by indirect immunofluorescence assay (IFA). Unit: Positive or Negative; Titer

  32. The Levels of Anti-Glycoprotein 210 (Anti-gp210)

    Time frame: Baseline, Weeks 12, 24, 36, 48

    Anti-gp210 detected by indirect immunofluorescence assay (IFA). Unit: Positive or Negative; Titer

  33. The Levels of Anti-Nuclear Pore Protein 100 (Anti-sp100)

    Time frame: Baseline, Weeks 12, 24, 36, 48

    Anti-sp100 detected by indirect immunofluorescence assay (IFA). Unit: Positive or Negative; Titer

  34. The Levels of Antimitochondrial Antibody M2 (AMA-M2)

    Time frame: Baseline, Weeks 12, 24, 36, 48

    AMA-M2 detected by indirect immunofluorescence assay (IFA). Unit: Positive or Negative; Titer

  35. The Levels of Anti-Sjogren Syndrome B Antibody (Anti-SS-B)

    Time frame: Baseline, Weeks 12, 24, 36, 48

    Anti-SS-B detected by indirect immunofluorescence assay (IFA). Unit: Positive or Negative; Titer

  36. The Levels of Anti-Sjogren Syndrome A Antibody (Anti-SS-A)

    Time frame: Baseline, Weeks 12, 24, 36, 48

    Anti-SS-A detected by indirect immunofluorescence assay (IFA). Unit: Positive or Negative; Titer

Study contacts

Contact information is provided by the study sponsor or research team.

Liyun Fu

CONTACT

[email protected]

+86 13777966906

Mengyuan Hu

CONTACT

[email protected]

+86 17858767819

Sponsors and collaborators

Lead sponsor

Ningbo No.2 Hospital

Other

Collaborators

  • Ningbo Medical Center Lihuili Hospital
  • Ningbo Mingzhou Hospital (Affiliated to Zhejiang University)
  • Shulan (Hangzhou) Hospital

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2034
Study completion
2035
First posted
Apr 28, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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