Status:
UNKNOWN
Clinical Efficacy and Safety of EGFR-TKI Combined With Nimotuzumab in the Treatment of Leptomeningeal Metastases From Lung Cancer
Lead Sponsor:
Hui Bu
Conditions:
Leptomeningeal Metastasis
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Clinical Efficacy and Safety of EGFR-TKI Combined With Nimotuzumab in the Treatment of Leptomeningeal Metastases From Lung Cancer.
Eligibility Criteria
Inclusion
- age 18 years or older, gender not limited;
- A definite diagnosis of Leptomeningeal metastases from lung cancer, including cerebrospinal fluid cytology and/or neuroimaging;
- Have a clear history of lung cancer, including histopathological diagnosis, or cytopathology combined with imaging diagnosis
- Patients who received any of EGFR inhibitors (gefitinib, erlotinib, afatinib, osimertinib etc.) meet the diagnostic criteria for secondary resistance and were in a slow progression stage
- Detection results of cerebrospinal fluid, blood gene or lung tissue specimens showed EGFR mutation, and immunohistochemistry results of cerebrospinal fluid, blood gene or lung tissue showed positive EGFR expression
- Bone marrow, liver, kidneys and blood clotting function are relatively stable
Exclusion
- Eastern Cooperative Oncology Group scored \> 2 points
- Patients had poor compliance, or for other reasons the investigator considered them unsuitable to participate in the study
Key Trial Info
Start Date :
April 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 19 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04833205
Start Date
April 19 2021
End Date
April 19 2023
Last Update
April 20 2021
Active Locations (2)
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1
The Second Hospital of Hebei Medical University
Hebei, Shijiazhuang/hebei, China, 050000
2
The Second Hospital of Hebei Medical University
Hebei, China