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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endostatin Therapy for NSCLC of LM | Experimental | 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 . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Human Endostatin | Drug | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui Bu | Contact | 86-13831106903 | buhuimy1@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hui Bu | The Second Hospital of Hebei Medical University | Principal Investigator |
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| ID | Term |
|---|---|
| D055756 | Meningeal Carcinomatosis |
| ID | Term |
|---|---|
| D008577 | Meningeal Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D043169 | Endostatins |
| ID | Term |
|---|---|
| D043165 | Angiostatic Proteins |
| D042501 | Angiogenic Proteins |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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|
| intrathcal methotrexate | Drug | Intrathecal chemotherapy specified dose on specified days. |
|
| Targeted drugs for non-small cell lung cancer | Drug | 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 . |
|
| 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 |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D043170 | Collagen Type XVIII |
| D024041 | Non-Fibrillar Collagens |
| D003094 | Collagen |
| D016326 | Extracellular Matrix Proteins |
| D012596 | Scleroproteins |
| D001685 | Biological Factors |