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

• Conditions: Non Small Cell Lung Cancer; Hepatitis B
• Interventions: Drug: Entecavir 1Mg Oral Tablet

• Registration Number: NCT03680183
• Lead Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University

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 Timeline

• Study Start: 2018-05-22
• Status Verified: 2018-09
• Study First Submitted: 2018-09-13
• Study First Submitted QC: 2018-09-19
• Study First Posted: 2018-09-21
• Last Update Submitted: 2018-09-26
• Last Update Posted: 2018-09-28
• Primary Completion: 2019-03-01
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-exposure	Entecavir 1Mg Oral Tablet	Entecavir 1Mg Oral Tablet
Pre-exposure	Entecavir 1Mg Oral Tablet	Entecavir 1Mg Oral Tablet

Primary Outcome Measures

Name	Time	Method
Average plasma concentration of the drugs (TKIs)	one year after recruit	compare the concentration of TKIs prior to and after anti-HBV treatment

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse reaction caused by TKIs	one year after recruit	the adverse reaction of TKIs before and after anti-HBV treatment

Trial Locations

Locations (1)

Affiliated Cancer Hospital & Institute of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China