Hepatitis B, Non Small Cell Lung Cancer
Conditions
Keywords
Tyrosine kinase inhibitors, pharmacokinetics, Hepatitis B
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.
Interventions
DRUGEntecavir 1Mg Oral Tablet
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)
Sponsors
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average plasma concentration of the drugs (TKIs) | one year after recruit | compare the concentration of TKIs prior to and after anti-HBV treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse reaction caused by TKIs | one year after recruit | the adverse reaction of TKIs before and after anti-HBV treatment |
Countries
China
Contacts
Primary ContactWenying Shu, PhD
Outcome results
None listed