Spots Global Cancer Trial Database for Clinical Pharmacokinetics of TKIs in Chinese Patients of Hepatitis B (HBV)

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Trial Identification

Brief Title: Clinical Pharmacokinetics of TKIs in Chinese Patients of Hepatitis B (HBV)

Official Title: Clinical Pharmacokinetics of Tyrosine Kinase Inhibitors in Chinese Patients of Hepatitis B

Study ID: NCT03680183

Conditions

Non Small Cell Lung Cancer

Hepatitis B

Interventions

Entecavir 1Mg Oral Tablet

Study Description

Brief Summary: 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.

Detailed Description: 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.