An Observational Research Of Crizotinib's Hepatic Toxicity In Non-small Cell Lung Cancer Patients

Sun Yat-sen University

Status: Unknown

Conditions: Non-Small Cell Lung Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT02708667

2015-FXY-078-Internal medicine

Details and patient eligibility

About

Crizotinib, an inhibitor of anaplastic lymphoma kinase (ALK), was approved by Food and Drug Administration (FDA) for the treatment of patients with ALK-positive non-small cell lung cancer (NSCLC) and its administration has achieved considerable success. However, adverse effects inevitably occurred and the most common one was hepatic toxicity, appearing as elevating alanine aminotransferase(ALT) and aspartate aminotransferase(AST). Therefore, the investigators try to figure out the mechanism of crizotinib-inducing hepatic toxicity, and explore whether there is any biological marker to diagnose this side effect in an early stage, which may realize individualized therapy with more efficacy and less side effects.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. patients who were histologically and cytologically confirmed NSCLC at stage III or IV
2. harbored ALK fusion gene and took crizotinib
3. age:18~75years
4. Eastern cooperative oncology group performance status(ECOG PS): 0~2 points
5. the expected lifetime is more than 12 weeks after being recruited

Exclusion criteria

1. patients who also suffered from other malignant tumor
2. uncontrolled systemic diseases,central nervous system (CNS) metastasis
3. clinically active interstitial lung diseases
4. severe liver dysfunction caused by hepatic cirrhosis or hepatitis （Child-Pugh class C, total index score 10-15 points）
5. taking drugs that interact with crizotinib