Clinical trial · Interventional
Icotinib in Advanced Non-small Cell Lung Cancer (NSCLC) With Hepatic Insufficiency
Safety Assessment of Icotinib in Advanced NSCLC Patients With Hepatic Insufficiency: A Multi-center, Open-label, Single-arm Study
NCT02062515CI-TRIAL-00018555unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to determine whether Icotinib is efficient and safe in treating advanced non-small cell lung cancer (NSCLC) patients with hepatic insufficiency.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| icotinib | Drug | Icotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Icotinib
- description
- Icotinib is administered orally 125 mg three times per day continuously for four weeks
- interventionNames
- Drug: icotinib
Primary outcomes (1)
- measure
- Number of Participants with Adverse Events
- timeFrame
- Up to 4 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of IIIB/IV stage NSCLC patients who are not suitable for surgery or radiotherapy * ECOG performance status points (PS) is 0-2 * Liver function: A (mild hepatic dysfunction): A1) total bilirubin within normal limit (ULN), while AST\> ULN; A2) total bilirubin within1.0-1 .5 × ULN; B (moderate hepatic dysfunction): total bilirubin within1.5-3 .0 × ULN * No malabsorption or other gastrointestinal disorders effecting drug absorption * Life expectancy: more than 12 weeks. Exclusion Criteria: * Previous usage of HER/EGFR inhibitors or other target molecule drugs ( small molecule drugs or monoclonal antibody therapy ) * Patients requires liver shunt , stent placement, or radiotherapy when 2 weeks before the start of the study or research process . * Patients with active hepatitis and cirrhosis.
References
Publications (0)
Data not yet available
No reference posted for this study.