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

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Status

Unknown

Conditions

Hepatitis B

Non Small Cell Lung Cancer

Treatments

Drug: Entecavir 1Mg Oral Tablet

Study type

Observational

Funder types

Other

Identifiers

NCT03680183

PTKI-HBV-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria