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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
156
Shulan (Hangzhou) Hospital
Hangzhou, Zhejiang, China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
Ningbo Mingzhou Hospital (Affiliated to Zhejiang University)
Ningbo, Zhejiang, China
Ningbo No.2 Hospital
Ningbo, Zhejiang, China
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
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
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
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
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
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
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
Overall survival (OS)
Time from enrollment to death from any cause, regardless of the cause of death. Unit: Months
Time frame: Years 1, 2, 3, 5
Concentration of Interleukin-2 (IL-2)
Serum levels of IL-2 will be measured using cytometric bead array (CBA). Unit: pg/mL
Time frame: Baseline, Week 24, Week 48
Concentration of Interleukin-4 (IL-4)
Serum levels of IL-4 will be measured using cytometric bead array (CBA). Unit: pg/mL
Time frame: Baseline, Week 24, Week 48
Concentration of Interleukin-6 (IL-6)
Serum levels of IL-6 will be measured using cytometric bead array (CBA). Unit: pg/mL
Time frame: Baseline, Week 24, Week 48
Concentration of Interleukin-10 (IL-10)
Serum levels of IL-10 will be measured using cytometric bead array (CBA). Unit: pg/mL
Time frame: Baseline, Week 24, Week 48
Concentration of Tumor Necrosis Factor-α (TNF-α)
Serum levels of TNF-α will be measured using cytometric bead array (CBA). Unit: pg/mL
Time frame: Baseline, Week 24, Week 48
Concentration of Interferon-γ (IFN-γ)
Serum levels of IFN-γ will be measured using cytometric bead array (CBA). Unit: pg/mL
Time frame: Baseline, Week 24, Week 48
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.