Real-world Study on Liver Cancer Risk in Chronic Hepatitis B Patients With Family History of Liver Cancer

ConditionsHBV HCC

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age30+

SponsorPeking University First Hospital

About this trial

This study is a prospective, multicenter, real-world cohort study designed to compare the long-term outcomes of chronic hepatitis B patients with a family history of HBV-related hepatocellular carcinoma (HCC) who receive PEG IFNα-2b combined with nucleos(t)ide analogues or nucleos(t)ide monotherapy. The primary endpoint is the incidence rate of HCC, and secondary endpoints include the rate of HBsAg seroclearance, changes in liver fibrosis, and survival rates. The study will last for 5 years and enroll approximately 15,000 patients, aiming to provide evidence-based optimization for CHB treatment regimens.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

(1) Chronic hepatitis B (CHB) patients with HBsAg positivity for over 6 months; (2) Family history of HBV-related hepatocellular carcinoma (HCC) (first- or second-degree relatives with HBV-related HCC); (3) Age ≥ 30 years, regardless of gender; (4) Based on real-world clinical practice, patients receiving nucleos(t)ide analogue (NA) therapy, such as Entecavir (ETV), Tenofovir Disoproxil Fumarate (TDF), Tenofovir Alafenamide Fumarate (TAF), or Tenofovir Amibufenamide (TMF), or those receiving combination therapy with nucleos(t)ide analogues and PEG IFNα-2b; (5) Negative pregnancy test within 24 hours before the first dose (for women of childbearing potential); (6) Voluntary participation, with the ability to understand and sign the informed consent form.

Disqualifiers

(1) Patients diagnosed with hepatocellular carcinoma (HCC) or malignancies in other organ systems prior to treatment; (2) Patients with contraindications to Peg IFN α-2b (refer to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition) for details); (3) Patients in the immune-tolerant phase of HBV infection; (4) Patients scheduled for or with a history of organ transplantation; (5) Patients with hypersensitivity to interferon or any contraindication listed in the drug's prescribing information; (6) Other conditions deemed unsuitable for enrollment by the investigator.

Trial population

Patients who meet the inclusion criteria but do not meet the exclusion criteria were screened from multiple centers nationwide.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

ETV,TDF,TAF,TMF combination with PEG IFNα-2b
Drug
The study will not involve any additional interventions, nor will it interfere with any related clinical decision-making.
ETV,TDF,TAF or TMF
Drug
The study will not involve any additional interventions, nor will it interfere with any related clinical decision-making.

Treatment groups

1,500 Participants

are divided into 2 treatment groups

Group A: PEG IFNα-2b Group1 intervention

Group B: Nucleos(t)ide Monotherapy Group1 intervention