Clinical Pharmacokinetics of Tyrosine Kinase Inhibitors in Chinese Patients of Hepatitis B
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Average plasma concentration of the drugs (TKIs)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Pre-exposure
Entecavir 1Mg Oral Tablet
Intervention: Entecavir 1Mg Oral Tablet (Drug)
Post-exposure
Entecavir 1Mg Oral Tablet
Intervention: Entecavir 1Mg Oral Tablet (Drug)
Outcomes
Primary Outcomes
Average plasma concentration of the drugs (TKIs)
Time Frame: one year after recruit
compare the concentration of TKIs prior to and after anti-HBV treatment
Secondary Outcomes
- Incidence of adverse reaction caused by TKIs(one year after recruit)
Investigators
Tian-Tian Cheng
Secretary of GCP
Affiliated Cancer Hospital & Institute of Guangzhou Medical University