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

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04680598
• Other study ID #: SH003
• Status: Recruiting
• Start date: December 25, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• ICI
Patients received ICI, including PD-1 inhibitor (pembrolizumab, toripalimab, nivolumab, sintilimab, camrelizumab) or PD-L1 inhibitor (atezolizumab)
• Antiviral Prophylaxis
Patient received concurrent antiviral prophylaxis, such as tenofovir, entecavir

Locations

Country	Name	City	State
China	Cancer Center Sun Yat-sen University	Guangzhou	Guangdong
China	Guangzhou Twelfth People 's Hospital	Guangzhou	Guangdong
China	Kaiping Central Hospital	Kaiping	Guangdong
China	ZhongShan People 's Hospital	Zhongshan

Sponsors (4)

Lead Sponsor	Collaborator
Sun Yat-sen University	Guangzhou No.12 People's Hospital, Kaiping Central Hospital, ZhongShan People 's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBV Reactivation rate	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)	2 months
Secondary	HBV-associated hepatitis	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	2 months
Secondary	PD-1 inhibitor disruption due to hepatitis	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.	2 months
Secondary	overall survival		12 months
Secondary	adverse event		30 Days after ICI