Clinical Pharmacokinetics of Tyrosine Kinase Inhibitors in Chinese Patients of Hepatitis B
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Average plasma concentration of the drugs (TKIs)
研究概览
简要总结
The study will explore the characteristics in clinical pharmacokinetics of gefitinib, erlotinib,afatinib,osimertinib, crizotinib, apatinib, icotinib in Chinese patients of Non-small-cell lung cancer and hepatitis B. The study is self-controlled. The plasma concentration of tyrosine kinase inhibitors will be analyzed before and after system treatment of HBV.
详细描述
Tyrosine kinase inhibitors (TKIs) are first line treatment for non-small-cell lung cancer patients with mutations in targeted genes. TKIs are metabolized in liver into inactive metabolites before eliminating from body. Liver function might plays a significant role in inter-individual differences of pharmacokinetics of TKIs. Hepatitis B is a disease of high prevalence in south China. The liver function will be compromised if the infection of hepatitis B virus has not been controlled. This study aims to compare the pharmacokinetics of TKIs before and after controlling HBV with standard treatment in Chinese patients of non-small-cell lung cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathological confirmed non-small-cell lung cancer
- •with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genetic mutation required by different TKIs
- •liver function, ALT and/or AST <= 2*upper limit of normal (ULN)
- •diagnosed of chronic hepatitis B
- •Hepatitis B negative as controlled group
- •receiving one type of TKIs
- •Age between 18-70
排除标准
- •diagnosed of acute/ active hepatitis B
- •diagnosed of AIDS
- •unable to make decision because of metastasis to central nervous system
研究组 & 干预措施
Pre-exposure
Entecavir 1Mg Oral Tablet
干预措施: Entecavir 1Mg Oral Tablet (Drug)
Post-exposure
Entecavir 1Mg Oral Tablet
干预措施: Entecavir 1Mg Oral Tablet (Drug)
结局指标
主要结局
Average plasma concentration of the drugs (TKIs)
时间窗: one year after recruit
compare the concentration of TKIs prior to and after anti-HBV treatment
次要结局
- Incidence of adverse reaction caused by TKIs(one year after recruit)
研究者
Tian-Tian Cheng
Secretary of GCP
Affiliated Cancer Hospital & Institute of Guangzhou Medical University