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

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

Observational The First Affiliated Hospital of Zhengzhou University · NCT07169656

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.

Quick facts

Study typeObservational
Enrollment15000 (estimated)
Ages18 Years and up
SexAll
SponsorThe First Affiliated Hospital of Zhengzhou University Academic / other
Locations162 sites (Anyang and 161 other locations)
Trial IDNCT07169656 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility criteria

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 this trial is running

Anyang and 161 other locations

+112 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Hepatitis b
Last reviewed 2026-06-13 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.