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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-exposure | Entecavir 1Mg Oral Tablet |
| |
| Post-exposure | Entecavir 1Mg Oral Tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entecavir 1Mg Oral Tablet | Drug | 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) |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Chinese patients diagnosed of non-small-cell lung cancer. Controlled group are HBV negative and HBV group are diagnosed of chronic hepatitis B. All subjects should be able to make their own decision and sign informed concerned.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenying Shu, PhD | Contact | 86-20-66673666 | 2006 | 790840799@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Shuzhong Cui, MD | Affiliated Cancer Hospital & Institute of Guangzhou Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Cancer Hospital & Institute of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510182 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C413685 | entecavir |
| D013607 | Tablets |
| C477843 | bicyclol |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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5ml of whole blood is collected before and after the anti-HBV treatment to measure the plasma concentration of TKIs
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |