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Clinical Trials in China / NCT07007286
Starting soon Observational

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

NCT07007286 · tracked via the Priya Life Science China tracker
Sponsor
Peking University First Hospital
Phase
Observational
Started
2025-06
Last updated
2025-06-05

Condition(s) studied

HBVHCC

Investigational drug(s) / intervention(s)

ETV,TDF,TAF,TMF combination with PEG IFNα-2bETV,TDF,TAF or TMF

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

ETV,TDF,TAF or TMF: The study will not involve any additional interventions, nor will it interfere with any related clinical decision-making.

Study 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.

Eligibility

Sex
ALL
Min age
30 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (555)

FacilityCityRegionStatus
Qitaihe Infectious Disease Hospital Heilongjiang Heilongjiang
Yizheng People's Hospital Yizheng Jiangsu
Changle County People's Hospital Changle Shandong
Juxian People's Hospital Junxian Shandong
Pingdu People's Hospital, Shandong Pingdu Shandong
Zouping People's Hospital Zouping Shandong
Huozhou Coal & Electricity Group General Hospital Co., Ltd. Huozhou Shanxi
Huozhou People's Hospital, Huozhou Medical Group Huozhou Shanxi
Huozhou People's Hospital Huozhou Shanxi
Fenxi Mining Group Employees General Hospital Jiexiu Shanxi
Jiexiu Medical Group People's Hospital Jiexiu Shanxi
Anfu County People's Hospital Anfu China
Ankang Central Hospital Ankang China
Ankang Hospital of Traditional Chinese Medicine Ankang China
Anning Hospital of Traditional Chinese Medicine Anning China
Anqing First People's Hospital Anqing China
Anqing Municipal Hospital Anqing China
Anshan Infectious Disease Hospital Anshan China
Anyue County People's Hospital Anyue China
Affiliated Hospital of Youjiang Medical University for Nationalities Baise City China
Baoding First Central Hospital Baoding China
Baoding People's Hospital Baoding China
Baotou Central Hospital Baotou China
China National Medicines (CNM) Northern Hospital Baotou China
The Third Staff Hospital of Baotou Steel Group Baotou China
Beihai People's Hospital Beihai China
Beijing Daxing District People's Hospital Beijing China
Beijing Ditan Hospital, Capital Medical University Beijing China
Beijing Ditan Hospital Beijing China
Beijing Fangshan District First Hospital Beijing China
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University Beijing China
Beijing Huaxin Hospital Beijing China
Beijing Liangxiang Hospital, Fangshan District Beijing China
Beijing Tsinghua Changgung Hospital Beijing China
Beijing You'an Hospital, Capital Medical University Beijing China
Beijing You'an Hospital Beijing China
Dongfang Hospital, Beijing University of Chinese Medicine Beijing China
Dongzhimen Hospital, Beijing University of Chinese Medicine Beijing China
Peking University People's Hospital Beijing China
Peking University Third Hospital Beijing China

+ 515 more sites — see the full list on the official registry below.

More Peking University First Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07007286 on ClinicalTrials.gov ↗ ← All trials in China