Hepatocellular Carcinoma
Conditions
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 carcinoma (HCC). However, the safety of ICI in patients with a high HBV-DNA load is unknown because of the potential risk of hepatitis B virus (HBV) reactivation. This study was to compare the HBV reactivation between patients with low HBV-DNA loads and high HBV-DNA loads undergoing antiviral prophylaxis and ICI.
Interventions
DRUGICI
Patients received ICI, including PD-1 inhibitor (pembrolizumab, toripalimab, nivolumab, sintilimab, camrelizumab) or PD-L1 inhibitor (atezolizumab)
DRUGAntiviral Prophylaxis
Patient received concurrent antiviral prophylaxis, such as tenofovir, entecavir
Sponsors
Kaiping Central Hospital
Guangzhou No.12 People's Hospital
ZhongShan People 's Hospital
Sun Yat-sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HBV Reactivation rate | 2 months | HBV Reactivation rate was defined as one of the following according to the American Association for the Study of Liver Diseases (AASLD) 2018 hepatitis B guidelines: (i) a ≥2 log (100-fold) increase in HBV DNA compared to the baseline level, (ii) HBV DNA ≥3 log (1,000) IU/mL in a patient with previously undetectable level (since HBV DNA levels fluctuate) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 12 months | — |
| adverse event | 30 Days after ICI | — |
| HBV-associated hepatitis | 2 months | HBV-associated hepatitis was defined as HBV Reactivation plus an ALT increase to ≥3 times the baseline level and \>100 U/L according to the AASLD 2018 Hepatitis B Guidance |
| PD-1 inhibitor disruption due to hepatitis | 2 months | PD-1 inhibitor disruption due to hepatitis was defined as either premature termination or a delay of at least 7 days between PD-1 inhibitor cycles because of hepatitis. |
Countries
China
Outcome results
None listed