Clinical trial · Observational
An Observational Research Of Crizotinib's Hepatic Toxicity In Non-small Cell Lung Cancer Patients
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- number of patients with adverse events
- timeFrame
- change from the date of taking crizotinib at 9 months
Secondary outcomes (1)
- measure
- progression free survival
- timeFrame
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available