Clinical trial Recruiting at 162 sites Observational Ages 18 and up

Reducing liver cancer risk in people with chronic hepatitis B — Zhiyuan Project

Official title: Observation Study on Reducing the Risk of Liver Cancer Associated With Hepatitis B (Zhiyuan) Project.

Run by The First Affiliated Hospital of Zhengzhou University · NCT07169656 · Data updated 2026-11-12

This project will follow adults with chronic hepatitis B who are receiving common antiviral or pegylated interferon treatments to see if different therapies affect liver cancer risk and other long-term outcomes.

More Chronic Hepatitis B trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment15000 (estimated)
SponsorThe First Affiliated Hospital of Zhengzhou University
Academic / other
Locations162 sites (Anyang and 161 other locations)
StatusRecruiting
StartedJune 3, 2024
Main results expectedJune 30, 2032
Study endsDecember 31, 2032
Registry record updatedSeptember 12, 2025
Trial IDNCT07169656 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18 years) with chronic HBV infection (HBsAg positive for ≥6 months) who are planned or currently treated with entecavir, TDF, TAF, TMF, or pegylated interferon α-2b and can provide informed consent are ideal candidates.

Probably not a fit

Patients with severe hepatic dysfunction or decompensated cirrhosis, existing hepatocellular carcinoma, or those enrolled in other interventional trials are unlikely to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, prospective, observational real-world study collecting treatment and outcome data from adults with chronic hepatitis B across hospitals in China. Participants receiving commonly used antivirals (entecavir, TDF, TAF, TMF) or pegylated interferon α-2b will be followed under usual-care conditions to compare outcomes such as viral suppression, liver function, hepatocellular carcinoma development, and markers related to functional cure. Patients with decompensated cirrhosis, existing hepatocellular carcinoma, or concurrent participation in other interventional trials are excluded, and written informed consent is required. The study aims to analyze real-world treatment patterns and long-term outcomes to inform optimized treatment and follow-up strategies.

Why it matters

Potential benefit: If successful, the study could identify which commonly used therapies are linked to lower liver cancer risk and better long-term outcomes, helping clinicians personalize treatment and monitoring.

How similar studies have gone: Previous randomized trials and observational cohorts have shown that nucleos(t)ide analogs and pegylated interferon can reduce disease progression and HCC risk, but comprehensive real-world comparisons across many hospitals are less common.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 1.Chronic HBV infection (HBsAg-positive for ≥6 months); 2.Age ≥18 years; 3.Patients who, based on real-world clinical practice needs, are planned or currently receiving treatment with:Entecavir (ETV),Tenofovir disoproxil fumarate (TDF),Tenofovir alafenamide fumarate (TAF),Tenofovir amibufenamide (TMF) OR Pegylated interferon α-2b-naïve patients OR Patients re-initiating pegylated interferon α-2b therapy; 4.Written informed consent obtained from the patient.

Exclusion Criteria:

* 1.Severe hepatic dysfunction or decompensated cirrhosis; 2.Concurrent participation in other clinical trials; 3.Hepatocellular carcinoma (HCC).

Where it's running

  • Huaxian People's Hospital
    Anyang, China
    Recruiting
  • Linzhou City People's Hospital
    Anyang, China
    Recruiting
  • Neihuang County People's Hospital
    Anyang, China
    Recruiting
  • Tangyin County People's Hospital
    Anyang, China
    Recruiting
  • The Fifth People's Hospital of Anyang
    Anyang, China
    Recruiting
  • The First Affiliated Hospital of Xinxiang Medical University (Hua County Branch)
    Anyang, China
    Recruiting
Show 44 more locations
  • Guangzhou First People's Hospital
    Guangzhou, China
    Recruiting
  • The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)
    Guangzhou, China
    Recruiting
  • Hebi Coal Mining Group General Hospital
    Hebi, China
    Recruiting
  • Hebi Infectious Disease Hospital
    Hebi, China
    Recruiting
  • Junxian County People's Hospital
    Hebi, China
    Recruiting
  • Bo'ai County People's Hospital
    Jiaozuo, China
    Recruiting
  • Mengzhou Hospital of Traditional Chinese Medicine
    Jiaozuo, China
    Recruiting
  • Qinyang People's Hospital
    Jiaozuo, China
    Recruiting
  • The Secend People's Hospital of Jiaozuo
    Jiaozuo, China
    Recruiting
  • The Third People's Hospital of Jiaozuo
    Jiaozuo, China
    Recruiting
  • Xiuwu People's Hospital
    Jiaozuo, China
    Recruiting
  • Wenxian People's Hospital
    Jiayuguan, China
    Recruiting
  • Jiyang County Hospital of Traditional Chinese Medicine
    Jinan, China
    Recruiting
  • Shandong Public Health Clinical Center
    Jinan, China
    Recruiting
  • Jiyuan People's Hospital
    Jiyuan, China
    Recruiting
  • Jiyuan Traditional Chinese Medicine Hospital
    Jiyuan, China
    Recruiting
  • Huaihe Hospital of Henan University
    Kaifeng, China
    Recruiting
  • Infectious Diseases Hospital of Kaifeng
    Kaifeng, China
    Recruiting
  • Kaifeng Central Hospital
    Kaifeng, China
    Recruiting
  • Kaifeng Hospital of Traditional Chinese Medicine
    Kaifeng, China
    Recruiting
  • Lankao First Hospital Group
    Kaifeng, China
    Recruiting
  • Qixian People's Hospital
    Kaifeng, China
    Recruiting
  • The People's Hospital of Weishi
    Kaifeng, China
    Recruiting
  • Tongxu County People's Hospital
    Kaifeng, China
    Recruiting
  • Weishi County People's Hospital
    Kaifeng, China
    Recruiting
  • Linyi Hospital of Traditional Chinese Medicine
    Linyi, China
    Recruiting
  • Linyi People's Hospital
    Linyi, China
    Recruiting
  • Linying County People's Hospital
    Luohe, China
    Recruiting
  • Luohe Central Hospital
    Luohe, China
    Recruiting
  • Luanchuan County People's Hospital
    Luoyang, China
    Recruiting
  • Luoning County People's Hospital
    Luoyang, China
    Recruiting
  • Luoyang Central Hospital
    Luoyang, China
    Recruiting
  • Luoyang First People's Hospital
    Luoyang, China
    Recruiting
  • Luoyang Third People's Hospital
    Luoyang, China
    Recruiting
  • Ruyang County People's Hospital
    Luoyang, China
    Recruiting
  • The First Affiliated Hospital of Henan University of Science and Technology
    Luoyang, China
    Recruiting
  • Xin'an County People's Hospital
    Luoyang, China
    Recruiting
  • Yichuan County Hospital of Traditional Chinese Medicine
    Luoyang, China
    Recruiting
  • Yiyang County People's Hospital
    Luoyang, China
    Recruiting
  • Dengzhou Central Hospital
    Nanyang, China
    Recruiting
  • Dengzhou People's Hospital
    Nanyang, China
    Recruiting
  • Fangcheng County People's Hospital
    Nanyang, China
    Recruiting
  • Nanyang Central Hospital
    Nanyang, China
    Recruiting
  • Nanyang First People's Hospital
    Nanyang, China
    Recruiting

+112 more sites. See ClinicalTrials.gov for the full list.

Study contacts

  • Principal investigator: Hongxia Liang — The First Affiliated Hospital of Zhengzhou University
  • Study coordinator: Hongxia Liang
  • Email: hxliang@zzu.edu.cn
  • Phone: 18595871806

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.