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

Sun Yat-sen University50 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Non-Small Cell Lung Cancer

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Outcomes

Primary Outcomes

number of patients with adverse events

Time frame: change from the date of taking crizotinib at 9 months

Secondary Outcomes

progression free survival

Time frame: from the date of taking crizotinib to the date of objective tumor progression or date of death from any cause,whichever came first,assessed up to 48 months