Post-Radical Treatment Antiviral Strategies in HBV-Related Liver Cancer: Impact on Tumor Prognosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorShenzhen Third People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
The study population comprises adults aged 18 to 70 with HBV-related liver cancer who have undergone radical treatment (surgery or ablation). They are HBsAg-positive, with pathological confirmation of HCC and BCLC staging of 0 or A. Participants must have adequate liver function (Child-Pugh A), an expected survival of over 3 months, and provide informed consent. The study excludes those with prior systemic cancer treatments, other active malignancies, allergies to interferon, severe liver or renal dysfunction, and other significant health issues.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Intervention for Group 1
DrugParticipants 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.
Intervention for Group 2
DrugParticipants 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
3-Year Cumulative Recurrence Rate via MRI (LI-RADS)
1. Measurement Tool: Liver Imaging Reporting and Data System (LI-RADS v2018) 1.1 Primary modality: Dynamic contrast-enhanced MRI 1.2 Confirmatory criteria: 1.2.1 LI-RADS 5 (definite HCC): 1.2.1.1 Arterial hyperenhancement + 1.2.1.2 Portal venous washout ± 1.2.1.3 Capsule/threshold growth 1.2.2 Histopathology (biopsy) for equivocal cases 2. Definition: Proportion of participants with new intrahepatic lesions meeting LI-RADS 5 criteria or histologically confirmed HCC metastases within 3 years post-radical treatment. 3. Clinical Significance: Recurrence defined as: 3.1 Local (original site) 3.2 Intrahepatic (\>2 cm from resection margin) 3.3 Extrahepatic (metastases with biopsy confirmation)
Time frame
3 years post-radical treatment.Secondary outcomes
1
2-Year HBsAg Seroclearance Rate
* Measurement Tool: Architect HBsAg QT Assay * Definition: Proportion with HBsAg loss (\<0.05 IU/mL) * Directionality: Lower HBsAg levels indicate better response * Confirmation: Required at two timepoints ≥24 weeks apart
Time frame
2 years post-treatment initiation.2
2-Year HBV DNA undetectable rate
* Measurement Tool: COBAS® TaqMan HBV Test v2.0 * Definition: Proportion of participants achieving HBV DNA \<10 IU/mL (LLOQ) in two consecutive tests ≥6 months apart * Directionality: Lower values indicate better virological control
Time frame
2 years post-treatment initiation.3
Incidence of Adverse Events (AEs)
* Measurement Tool: CTCAE v5.0 grading system * Definition: Frequency of all-cause AEs, categorized by: * Severity: Grade 1 (mild) to 5 (death) * Relatedness: Definite/probable/possible vs. unrelated * Range: 1-5 scale (higher grade = worse severity) * Reporting Threshold: All events ≥Grade 2
Time frame
Throughout the 3-year follow-up period.4
Serious Adverse Event (SAE) Rate
* Measurement Tool: CTCAE v5.0 * Definition: Events meeting ≥1 SAE criterion: Death/life-threatening Hospitalization/prolonged hospitalization Persistent disability Congenital anomaly -Causality Assessment: Using WHO-UMC system
Time frame
Throughout the 3-year follow-up period.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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