NCT07120750Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 13 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 332 (estimated)
- First submitted
- 8 Jul 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Shenzhen Third People's Hospital
- NCT number
- NCT07120750
What you commit to
- Study type: Observational
- Planned participants: 332
- From 1 Sept 2025 to the primary completion date, 31 Dec 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Concurrent Participation in Other Trials:Participants who are concurrently involved in other clinical research trials will be excluded.
Other illness
- 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 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.
- Investigator's Judgment:Participants whom the investigator deems unsuitable for the study based on their current medical condition will be excluded.
Lab values
- Renal Impairment: Participants with serum creatinine levels exceeding 1.5 times the upper limit of normal will be excluded.
Other
- Severe Liver Dysfunction: Participants with severe liver dysfunction or decompensated cirrhosis 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.