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

Not yet recruiting

• Conditions: HBV; HCC
• Interventions: Drug: ETV,TDF,TAF,TMF combination with PEG IFNα-2b; Drug: ETV,TDF,TAF or TMF

• Registration Number: NCT07007286
• Lead Sponsor: Peking University First Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-28
• Study First Submitted QC: 2025-05-28
• Last Update Submitted: 2025-05-28
• Study Start: 2025-06
• Study First Posted: 2025-06-05
• Last Update Posted: 2025-06-05
• Primary Completion: 2032-01
• Study Completion: 2032-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• (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.

Exclusion Criteria

• (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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PEG IFNα-2b Group	ETV,TDF,TAF,TMF combination with PEG IFNα-2b	-
Nucleos(t)ide Monotherapy Group	ETV,TDF,TAF or TMF	-

Primary Outcome Measures

Name	Time	Method
5-year incidence of hepatocellular carcinoma (HCC)	From the start of antiviral treatment to 5 years of follow-up.

Secondary Outcome Measures

Name	Time	Method
HBsAg seroclearance rate	From the start of antiviral treatment to 5 years of follow-up.
HBeAg seroclearance rate	From the start of antiviral treatment to 5 years of follow-up.
HBV DNA level	From the start of antiviral treatment to 5 years of follow-up.
HBsAg level	From the start of antiviral treatment to 5 years of follow-up.
HBeAg level	From the start of antiviral treatment to 5 years of follow-up.
Proportion of patients with improved or progressed liver fibrosis	From the start of antiviral treatment to 5 years of follow-up.
Median time to cirrhosis	From the start of antiviral treatment to 5 years of follow-up.
Median time to decompensated cirrhosis	From the start of antiviral treatment to 5 years of follow-up.
Median time to HCC	From the start of antiviral treatment to 5 years of follow-up.
Overall survival (OS)	From the start of antiviral treatment to 5 years of follow-up.

Trial Locations

Locations (554)

Qitaihe Infectious Disease Hospital; 🇨🇳 Heilongjiang, Heilongjiang, China

Yizheng People's Hospital; 🇨🇳 Changzhou, China

Changle County People's Hospital; 🇨🇳 Changle, Shandong, China

Juxian People's Hospital; 🇨🇳 Junxian, Shandong, China

Pingdu People's Hospital, Shandong; 🇨🇳 Pingdu, Shandong, China

Zouping People's Hospital; 🇨🇳 Zouping, Shandong, China

Huozhou Coal & Electricity Group General Hospital Co., Ltd.; 🇨🇳 Huozhou, Shanxi, China

Huozhou People's Hospital, Huozhou Medical Group; 🇨🇳 Huozhou, Shanxi, China

Huozhou People's Hospital; 🇨🇳 Huozhou, Shanxi, China

Fenxi Mining Group Employees General Hospital; 🇨🇳 Jiexiu, Shanxi, China

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