NCT07120750

Post-Radical Treatment Antiviral Strategies in HBV-Related Liver Cancer: Impact on Tumor Prognosis

The Impact of Different Antiviral Strategies on Tumor Prognosis in Patients With HBV-related Liver Cancer After Radical Treatment: A Prospective, Open-label, Non-randomized Clinical Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 332 (estimated)
• Sponsor: Shenzhen Third People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if peginterferon alfa-2b can reduce the recurrence of HBV-related liver cancer in patients who have undergone radical treatment. The study will also explore the potential benefits of peginterferon alfa-2b in achieving clinical cure and its impact on reducing liver cancer recurrence. The trial is designed as a single-center, non-randomized, open-label study. Participants will be HBV-related liver cancer patients who have received radical treatment. The study will compare two groups: one receiving nucleos(t)ide analogues (NAs) alone and the other receiving NAs combined with peginterferon alfa-2b. The main question it aims to answer is: Can peginterferon alfa-2b lower the 3-year recurrence rate in HBV-related liver cancer patients after radical treatment? Participants will undergo regular follow-ups, including imaging studies and blood tests, to monitor for cancer recurrence and assess the safety of the treatment.

Detailed description

1. Study Background The 3-year recurrence rate of HBV-related liver cancer after radical surgery is as high as 40% to 70%. This study aims to explore whether the addition of peginterferon alfa-2b (Peg-IFNα-2b) to nucleoside (acid) analogues (NAs) can reduce the risk of recurrence through immune modulation. 2. Key Mechanism Hypotheses Peg-IFNα-2b may reduce the reactivation of micrometastases through: * Enhancing HBV-specific T-cell responses * Lowering serum HBsAg levels * Inhibiting immune suppression in the tumor microenvironment 3. Detection Methods * Imaging Monitoring: Abdominal MRI (using LI-RADS v2018 criteria) every 12 weeks ± 7 days. * Laboratory Tests: * HBV DNA: COBAS® TaqMan HBV Test (LLOQ = 10 IU/mL) * Quantitative HBsAg: Architect HBsAg QT assay * PBMC Immune Profile: Flow cytometry (proportion of CD8+/PD-1+ T cells) * Tissue Biomarkers: Postoperative tumor tissue PD-L1 immunohistochemistry (22C3 antibody) and T-cell infiltration score. 4. Statistical Design * Sample size: 332 cases (power 80%, α = 0.05, expected HR = 0.6) * Primary endpoint analysis: 3-year cumulative recurrence rate (Kaplan-Meier method + Log-rank test) * Covariate adjustment: Cox model includes age, BCLC stage, and baseline HBsAg level.

Conditions

• Hepatocellular Carcinoma (HCC)
• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	Intervention for Group 1	Participants will receive standard NAs therapy, which may include entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), or tenofovir amibufenamide (TMF). NAs are antiviral medications used to suppress HBV replication and manage chronic hepatitis B infection.
DRUG	Intervention for Group 2	Participants will receive Peg-IFNα-2b in addition to NAs therapy. Peg-IFNα-2b is an antiviral medication that works by boosting the immune system and has additional antiviral, antifibrotic, and anti-tumor effects. It is used to treat chronic hepatitis B and may help reduce the recurrence of liver cancer.

Timeline

• Start date: 2025-09-01
• Primary completion: 2029-12-31
• Completion: 2030-12-31
• First posted: 2025-08-13
• Last updated: 2025-08-13