Post-Radical Treatment Antiviral Strategies in HBV-Related Liver Cancer: Impact on Tumor Prognosis (PRTRAS 001)

Southern University of Science and Technology

Status: Not yet enrolling

Conditions: Chronic Hepatitis B; Hepatocellular Carcinoma (HCC)

Treatments: Drug: Intervention for Group 1; Drug: Intervention for Group 2

Study type: Observational

Funder types: Other

Identifiers

NCT07120750

IIT-2024-077

Details and patient eligibility

About

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.

Full 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.

Enrollment: 332 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: Participants must be between 18 and 70 years of age.
• HBsAg Positive: Participants must be positive for hepatitis B surface antigen (HBsAg).
• Confirmed Hepatocellular Carcinoma (HCC): Participants must have a pathological confirmation of HCC via surgical resection or local ablation.
• BCLC Staging: Participants must have a Barcelona Clinic Liver Cancer (BCLC) staging of 0 or A.
• Liver Function: Participants must have normal or well-compensated liver function, classified as Child-Pugh A.
• Expected Survival: Participants must have an expected survival of more than 3 months.
• Informed Consent: Participants must sign an informed consent form and agree to comply with the study requirements. If a participant is unable to sign the consent form, a legal guardian or agent must do so.

Exclusion criteria

• Prior Systemic Cancer Treatments: Participants who have received prior systemic cancer treatments such as liver transplantation, chemotherapy, targeted therapy, or biological therapy will be excluded.
• Other Active Malignancies: Participants with a history or presence of other active malignancies, except for skin basal cell carcinoma or squamous cell carcinoma that has been cured, or cervical carcinoma in situ, will be excluded.
• Allergies to Interferon: Participants who are allergic to interferon or any of its components, or whom the investigator deems unsuitable for interferon therapy, will be excluded.
• Other Chronic Liver Diseases: Participants with other chronic liver diseases such as hepatitis A, C, D, or E virus infection, alcoholic liver disease, genetic metabolic liver disease, or drug-induced liver disease will be excluded.
• Autoimmune Diseases:Participants with autoimmune diseases,including autoimmune liver disease and psoriasis, will be excluded.
• Severe Liver Dysfunction: Participants with severe liver dysfunction or decompensated cirrhosis will be excluded.
• Renal Impairment: Participants with serum creatinine levels exceeding 1.5 times the upper limit of normal will be excluded.
• Severe Systemic Diseases:Participants with severe systemic diseases affecting the heart,lungs,kidneys,brain,or blood will be excluded.
• Severe Neuropsychiatric Disorders:Participants with severe neuropsychiatric disorders such as epilepsy, depression, mania, or schizophrenia will be excluded.
• Unstable Medical Conditions:Participants with unstable diabetes,hypertension,hyperthyroidism,or other endocrine diseases will be excluded.
• Retinopathy:Participants with a history of severe retinopathy or other evidence of retinopathy will be excluded.
• Substance Abuse:Participants with a history of drug abuse or alcoholism will be excluded.
• Pregnancy or Breastfeeding:Pregnant or breastfeeding women, or women planning to become pregnant during the study period who are unwilling to use contraception, will be excluded.
• Investigator's Judgment:Participants whom the investigator deems unsuitable for the study based on their current medical condition will be excluded.
• Concurrent Participation in Other Trials:Participants who are concurrently involved in other clinical research trials will be excluded.