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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.
Patients with hepatic insufficiency is an important subgroup of who receive EGFR TKIs. Phase I/II studies showed that Icotinib has good security. Based on the above considerations, this single-arm, open-label study is designed to evaluate the safety of icotinib 125mg three times daily for histologically or cytologically confirmed NSCLC patients with hepatic insufficiency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Icotinib | Experimental | Icotinib is administered orally 125 mg three times per day continuously for four weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| icotinib | Drug | Icotinib is administered orally 125 mg three times per day continuously for four weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events | Up to 4 weeks |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hao Long, MD | Contact | 020-87343261 |
| Name | Affiliation | Role |
|---|---|---|
| Hao Long, MD | Sun Yat-sen Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C531470 | icotinib |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |