Efficacy and Safety of Recombinant Human Endostatin in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis

Study Overview
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Brief Summary
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The purpose of this study is to observe the clinical effect and safety of Recombinant Human Endostatin in non-small cell lung cancer with leptomeningeal metastasis

Official Title
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Efficacy and Safety of Recombinant Human Endostatin in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis

Conditions
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Leptomeningeal Metastasis

Intervention / Treatment
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* Drug: Recombinant Human Endostatin
* Drug: intrathcal methotrexate
* Drug: Targeted drugs for non-small cell lung cancer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 years old Pathologically proven non-small cell lung cancer Karnofsky performance status ≥ 40 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 . No severe abnormal liver and kidney function; Patients have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Evidence of bleeding diathesis or serious infection Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension) Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endostatin Therapy for NSCLC of LM<br>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 . | Drug: Recombinant Human Endostatin<br>* 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.<br>* Other names: Endostatin;Drug: intrathcal methotrexate<br>* Intrathecal chemotherapy specified dose on specified days.<br>Drug: Targeted drugs for non-small cell lung cancer<br>* 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 .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leptomeningeal Metastasis Overall survival | Leptomeningeal Metastasis Overall survival defined as time from LM diagnosis to death due to any cause or last follow-up | 36 months | 
| Neurological Progression Free Survival | From the start of treatment until central nervous system metastase progression or death due to any cause | 36 months | 
| The incidence of adverse reactions | From date of first dose up to assessed from April 2020 to April 2023 (In accordance with the standard of CTCAE) | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | ORR, proportion of patients with a best overall response of complete response or partial response (CR+PR) | 36 months | 
| Neurological assessment | In accordance with the standard of Response Assessment in Neuro-Oncology(RANO) Neurological Assessment group.The maximum value is 29 and the minimum value is 0.The higher scores mean a worse outcome. | 36 months | 
| progression-free survival | Proportion of patients progression-free by investigator assessment per RECIST v1.1 | 36 months | 
| Overall survival | defined as time from Non-Small Cell Lung Cancer diagnosis to death due to any cause or last follow-up | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recombinant Human Endostatin, Non-Small Cell Lung Cancer with Leptomeningeal Metastasis