Comparing HBV reactivation in patients with different HBV-DNA levels receiving immunotherapy
Official title: Comparison of Hepatitis B Virus Reactivation Between Patients With High HBV-DNA and Low HBV-DNA Loads Undergoing Immune Checkpoint Inhibitor and Concurrent Antiviral Prophylaxis: a Prospective Observational Study
Run by Sun Yat-sen University · NCT04680598 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study tests if patients with liver cancer and different levels of hepatitis B virus in their blood are at different risks for the virus becoming active again while receiving immune therapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 800 (estimated) |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 4 sites (Guangzhou, Guangdong and 3 other locations) |
| Trial ID | NCT04680598 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients diagnosed with hepatocellular carcinoma who are seropositive for hepatitis B and receiving antiviral prophylaxis while undergoing ICI treatment.
✕Probably not a fit
Patients with other positive viral markers or those lacking necessary HBV DNA and liver function testing will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the risk of hepatitis B virus (HBV) reactivation in patients with hepatocellular carcinoma (HCC) who have either high or low HBV-DNA loads while undergoing treatment with immune checkpoint inhibitors (ICIs) and concurrent antiviral prophylaxis. The study will compare the incidence of HBV reactivation between these two patient groups to better understand the safety of ICIs in the context of HBV. Participants must have a confirmed diagnosis of HCC and be seropositive for hepatitis B surface antigen, receiving antiviral therapy alongside ICI treatment. The findings could provide critical insights into managing HCC patients with HBV during immunotherapy.
Why it matters
Potential benefit: If successful, this study could help identify safer treatment protocols for HCC patients with varying HBV-DNA levels undergoing immunotherapy.
How similar studies have gone: While studies on HBV reactivation during immunotherapy exist, this specific comparison of high versus low HBV-DNA loads in HCC patients is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL) * Seropositive for hepatitis B surface antigen (HBsAg) * Received concurrent antiviral prophylaxis and at least one cycle of ICI treatment. Prior use of antiviral therapy was allowed * Adherence to antiviral therapy * A life expectancy of 3 months or more * An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2 Exclusion Criteria: * other positive viral markers, including IgM antibodies to hepatitis A virus, the hepatitis C virus viral load, IgG antibodies to hepatitis D virus, IgM antibodies to hepatitis E virus * Antibodies to human immunodeficiency virus, * A lack of HBV DNA and liver function testing before the first immunotherapy and during the follow-up period.
Where it's running
-
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China Recruiting -
Guangzhou Twelfth People 's Hospital
Guangzhou, Guangdong, China Recruiting -
Kaiping Central Hospital
Kaiping, Guangdong, China Recruiting -
ZhongShan People 's Hospital
Zhongshan, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.