An Observational Research on Relationship Between c-Met Gene Polymorphism, Promoter Methylation Level, Related Drug Metabolism Enzymes and Crizotinib's Hepatic Toxicity in Non-small Cell Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- number of patients with adverse events
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who were histologically and cytologically confirmed NSCLC at stage III or IV
- •harbored ALK fusion gene and took crizotinib
- •age:18~75years
- •Eastern cooperative oncology group performance status(ECOG PS): 0~2 points
- •the expected lifetime is more than 12 weeks after being recruited
排除标准
- •patients who also suffered from other malignant tumor
- •uncontrolled systemic diseases,central nervous system (CNS) metastasis
- •clinically active interstitial lung diseases
- •severe liver dysfunction caused by hepatic cirrhosis or hepatitis （Child-Pugh class C, total index score 10-15 points）
- •taking drugs that interact with crizotinib
结局指标
主要结局
number of patients with adverse events
时间窗: change from the date of taking crizotinib at 9 months
次要结局
- progression free survival(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)
研究者
Li-kun Chen
Associate Professor/Associate chief physician
Sun Yat-sen University