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The purpose of this study is to evaluate the efficacy and safety of dose escalation of Icotinib in advanced non small cell lung cancer (NSCLC) patients after the therapy of Icotinib, Iressa and Tarceva.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Icotinib | Experimental | Patients can accept the treatment with Icotinib (250/375/500mg tid) until disease progression or unacceptable toxicity occurred. The overall study period takes about 24 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Icotinib | Drug | Patients can accept the treatment with Icotinib (250/375/500mg tid) until disease progression or unacceptable toxicities occurred. The overall study period takes about 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| safety and efficacy |
| 2 years |
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Inclusion Criteria:
NSCLC patients were confirmed by histology or cytology
The time interval must be over 4 weeks from previous chemotherapy to registration to participate in this experiment if he or she received chemotherapy,and also have any toxicity to recover.
at least one measureable lesion accord to RECIST 1.1 criteria and the lesion accepted no radiotherapy.
ECOG 0-2 score
at least 12 weeks of expected survival time
Women of childbearing age must have a pregnancy test 7 days before treatment and the result were negative ,men of childbearing age: surgical sterilization or treatment during and after the end of three months to take contraceptive measures
understand and sign a written informed consent voluntarily.
Exclusion Criteria:
If the subject meet any of the following exclusion criteria ,he is no eligible to participate in this study,
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hu Liu, MD | Contact | 865512922987 | drliuhu@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yueyin Pan, MD | Anhui Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Oncology,The First Affiliated Hospital of Anhui Medical Univesrsity | Recruiting | Hefei | Anhui | 230032 | China |
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| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| C531470 | icotinib |
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