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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 4
- 主要终点
- HBV Reactivation rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
high HBV-DNA group
patients with HBV-DNA >500 IU/ml
干预措施: ICI (Drug)
high HBV-DNA group
patients with HBV-DNA >500 IU/ml
干预措施: Antiviral Prophylaxis (Drug)
low HBV-DNA group
patients with HBV-DNA≤500 IU/ml
干预措施: ICI (Drug)
low HBV-DNA group
patients with HBV-DNA≤500 IU/ml
干预措施: Antiviral Prophylaxis (Drug)
结局指标
主要结局
HBV Reactivation rate
时间窗: 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)
次要结局
- HBV-associated hepatitis(2 months)
- PD-1 inhibitor disruption due to hepatitis(2 months)
- overall survival(12 months)
- adverse event(30 Days after ICI)
研究者
Shi Ming
Proffessor
Sun Yat-sen University