Status:
UNKNOWN
Comparison of HBV Reactivation Between Patients With High HBV-DNA and Low HBV-DNA Loads Undergoing ICI and Concurrent Antiviral Prophylaxis: a Prospective Observational Study
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Kaiping Central Hospital
Guangzhou No.12 People's Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Brief Summary
Immune checkpoint inhibitor (ICI), including programmed cell death protein-1 (PD-1) inhibitor or programmed cell death-Ligand 1 (PD-L1) inhibitor , is recommended to treat advanced hepatocellular carc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 25 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT04680598
Start Date
December 25 2020
End Date
December 31 2023
Last Update
August 2 2023
Active Locations (4)
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1
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
2
Guangzhou Twelfth People 's Hospital
Guangzhou, Guangdong, China, 510620
3
Kaiping Central Hospital
Kaiping, Guangdong, China, 529300
4
ZhongShan People 's Hospital
Zhongshan, China