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Clinical Efficacy and Safety of EGFR-TKI Combined With Nimotuzumab in the Treatment of Leptomeningeal Metastases From Lung Cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leptomeningeal metastases received EGFR-TKI and Nimotuzumab | Experimental | The patients received Nimotuzumab 200 mg,which was diluted in 250mL 0.9% sodium chloride injection, intravenously dripping.And the duration of administration was controlled over 60 min), and the drug was used continuously for 8 weeks.One the other hand,the patient received the third generation of EGFR-TKI |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimotuzumab | Drug | Nimotuzumab 200 mg was diluted in 250mL 0.9% sodium chloride injection, intravenously dripping, the duration of administration was controlled over 60 min), and the drug was used continuously for 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | From the diagnosis of the LM to the time of disease worsen | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | From the diagnosis of theLM to the time of death | 2 years |
| Incidence of Treatment-Emergent Adverse Events | When the Nimotuzumab is used,we will observe if the patients have the allergic reaction,diarrhea ,vomiting and so on.Number of participants with treatment-related adverse events as assessed by CTCAE v4.0" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| hui bu, PhD | Contact | 0311-66003711-211 | buhuimy1@163.com | |
| jiao xue qi, master | Contact | 1074234012@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| jiao xue qi, master | The Second Hospital of Hebei Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Hebei Medical University | Recruiting | Hebei | Shijiazhuang/hebei | 050000 | China |
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| ID | Term |
|---|---|
| D055756 | Meningeal Carcinomatosis |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D008577 | Meningeal Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C501466 | nimotuzumab |
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|
| 8Weeks |
| The Second Hospital of Hebei Medical University | Recruiting | Hebei | China |
|
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |