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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Non Small Cell Lung Cancer, Hepatitis B

Intervention / Treatment
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* Drug: Entecavir 1Mg Oral Tablet


Participation Criteria
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Eligibility Criteria
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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: diagnosed of acute/ active hepatitis B diagnosed of AIDS unable to make decision because of metastasis to central nervous system

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-exposure<br>Entecavir 1Mg Oral Tablet | Drug: Entecavir 1Mg Oral Tablet<br>* The anti-HBV treatment includes a anti-HBV antibiotics and a drug of protecting liver cells or decrease alanine aminotransferase (ALT) or aspartate transaminase (AST)<br>* Other names: Bicyclol Tablets;|
| Post-exposure<br>Entecavir 1Mg Oral Tablet | Drug: Entecavir 1Mg Oral Tablet<br>* The anti-HBV treatment includes a anti-HBV antibiotics and a drug of protecting liver cells or decrease alanine aminotransferase (ALT) or aspartate transaminase (AST)<br>* Other names: Bicyclol Tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average plasma concentration of the drugs (TKIs) | compare the concentration of TKIs prior to and after anti-HBV treatment | one year after recruit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse reaction caused by TKIs | the adverse reaction of TKIs before and after anti-HBV treatment | one year after recruit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tyrosine kinase inhibitors, pharmacokinetics, Hepatitis B