Efficacy and Safety of Recombinant Human Endostatin in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis
NCT ID: NCT04356118
Last Updated: 2020-05-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
30 participants
INTERVENTIONAL
2020-06-30
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Endostatin Therapy for NSCLC of LM
Recombinant Human Endostatin + intrathcal methotrexate+Targeted drugs for non-small cell lung cancer
Recombinant Human Endostatin:15mg/endostatin;The dose is 7.5mg/㎡/d，Once a day for two weeks, take a week off,start the next cycle, up to four cycles.
intrathcal methotrexate :Intrathecal chemotherapy specified dose on specified days.
Targeted drugs for non-small cell lung cancer:
EGFR Mutation: Erlotinib，Afatinib，Osimertinib, et al. ALK ROS1 Mutation:Crizotinib,Ceritinib,Alectinib ,et al. BARF Mutation:Vemurafenib,et al. Other Mutation: other Targeted drugs .
Recombinant Human Endostatin
endostatin 7.5mg/㎡/d，Once a day for two weeks, take a week off,start the next cycle, up to four cycles .We advocate a highly individualized treatment plan according to each patients specific manifestations of the disease process.
intrathcal methotrexate
Intrathecal chemotherapy specified dose on specified days.
Targeted drugs for non-small cell lung cancer
EGFR Mutation: Erlotinib，Afatinib，Osimertinib, et al. ALK ROS1 Mutation:Crizotinib,Ceritinib,Alectinib ,et al. BARF Mutation:Vemurafenib,et al. Other Mutation: other Targeted drugs .
Interventions
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Recombinant Human Endostatin
endostatin 7.5mg/㎡/d，Once a day for two weeks, take a week off,start the next cycle, up to four cycles .We advocate a highly individualized treatment plan according to each patients specific manifestations of the disease process.
intrathcal methotrexate
Intrathecal chemotherapy specified dose on specified days.
Targeted drugs for non-small cell lung cancer
EGFR Mutation: Erlotinib，Afatinib，Osimertinib, et al. ALK ROS1 Mutation:Crizotinib,Ceritinib,Alectinib ,et al. BARF Mutation:Vemurafenib,et al. Other Mutation: other Targeted drugs .
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Pathologically proven non-small cell lung cancer
3. Karnofsky performance status ≥ 40
4. LM diagnosis was based on the detection of malignant cells in the CSF, the focal or diffuse enhancement of leptomeninges, and nerve roots or the ependymal surface on gadolinium-enhanced MRI .
5. No severe abnormal liver and kidney function;
6. Patients have the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
2. Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
3. Pregnant or lactating women
18 Years
ALL
No
Sponsors
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Hui Bu
OTHER
Responsible Party
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Hui Bu
Study Principal Investigator
Principal Investigators
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Hui Bu
Role: PRINCIPAL_INVESTIGATOR
The Second Hospital of Hebei Medical University
Central Contacts
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Other Identifiers
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BH 005
Identifier Type: -
Identifier Source: org_study_id
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