Clinical trial NCT04680598: 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Kaiping Central Hospital
name: Guangzhou No.12 People's Hospital
name: ZhongShan People 's Hospital
First posted: 2020-12-23
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients were divided into low HBV-DNA group (low group, ≤500 IU/ml) and high HBV-DNA group (high group, \>500 IU/ml) according to baseline HBV-DNA level. Baseline HBV-DNA was the HBV-DNA level within 2 weeks prior to initial ICI therapy. For patients who had prior experience with antiviral therapy, the antiviral therapy would be continued. For patients who did not have prior experience with antiviral therapy, antiviral therapy would be administered after patients was confirmed with positive HBsAg or positive HBV-DNA level. Prior use of antiviral therapy was defined that patients have taken antiviral therapy for a period of time before they received ICI therapy. Antiviral prophylaxis was defined as anti-HBV treatment administered before and during ICI therapy. Antiviral treatment was continued even though ICI therapy was terminated.

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.


Eligibility 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.

Primary outcomes:
measure: HBV Reactivation rate
timeFrame: 2 months
Secondary outcomes:
measure: HBV-associated hepatitis
timeFrame: 2 months
measure: PD-1 inhibitor disruption due to hepatitis
timeFrame: 2 months
measure: overall survival
timeFrame: 12 months
measure: adverse event
timeFrame: 30 Days after ICI
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Twelfth People 's Hospital
state: Guangdong
city: Kaiping
country: China
facility: Kaiping Central Hospital
state: Guangdong
city: Zhongshan
country: China
facility: ZhongShan People 's Hospital
Study officials:
References: