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

ConditionsHepatocellular CarcinomaHEPATITIS B CHRONICHepatitis B Chronic Infection
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNingbo No.2 Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Peginterferon alfa-2b

    Drug

    Peginterferon alfa-2b injection administered subcutaneously

  • TDF

    Drug

    Tenofovir disoproxil fumarate

  • TAF

    Drug

    Tenofovir alafenamide

  • TMF

    Drug

    Tenofovir amibufenamide

Treatment groups

156 Participants
are divided into 2 treatment groups
Group A: Peginterferon alfa-2b combined with NAsExperimental treatment 4 interventions
Group B: NAs aloneActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Concentration of Hepatitis B Surface Antigen (Hepatitis B Surface Antigen, HBsAg)

Serum HBsAg concentration assessed by Chemiluminescent Microparticle Immunoassay (CMIA). Unit: IU/mL

Time frame
Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240
2

Proportion of patients with HBsAg loss

Proportion of patients with HBsAg loss (HBsAg \< 0.05 IU/mL) determined by CMIA. Unit: % of patients

Time frame
Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240
3

Proportion of patients with HBsAg seroconversion

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

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

Secondary outcomes

1

Concentration of HBV DNA (Hepatitis B Virus Deoxyribonucleic Acid)

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

Time frame
Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240
2

Concentration of Hepatitis B e Antigen (HBeAg)

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

Time frame
Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240
3

Composition and diversity of intestinal microbiota

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

Time frame
Baseline, Week 24, Week 48
4

Recurrence-Free Survival (RFS)

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

Time frame
Years 1, 2, 3, 5

Other outcomes

1

The Levels of Thyroid Stimulating Hormone (TSH)

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

Time frame
Baseline, Weeks 12, 24, 36, 48
2

The Levels of Free Triiodothyronine (FT3)

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

Time frame
Baseline, Weeks 12, 24, 36, 48
3

The Levels of Free Thyroxine (FT4)

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

Time frame
Baseline, Weeks 12, 24, 36, 48
4

The Levels of Thyroglobulin Antibody (TgAb)

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

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ningbo No.2 Hospital

Lead sponsor

Ningbo Medical Center Lihuili Hospital

Collaborator

Ningbo Mingzhou Hospital (Affiliated to Zhejiang University)

Collaborator

Shulan (Hangzhou) Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: