Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT04356118
Status:
UNKNOWN
Last Update Posted:
2020-05-27
First Post:
2020-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Recombinant Human Endostatin in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055756', 'term': 'Meningeal Carcinomatosis'}], 'ancestors': [{'id': 'D008577', 'term': 'Meningeal Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D043169', 'term': 'Endostatins'}], 'ancestors': [{'id': 'D043165', 'term': 'Angiostatic Proteins'}, {'id': 'D042501', 'term': 'Angiogenic Proteins'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D043170', 'term': 'Collagen Type XVIII'}, {'id': 'D024041', 'term': 'Non-Fibrillar Collagens'}, {'id': 'D003094', 'term': 'Collagen'}, {'id': 'D016326', 'term': 'Extracellular Matrix Proteins'}, {'id': 'D012596', 'term': 'Scleroproteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-23', 'studyFirstSubmitDate': '2020-04-18', 'studyFirstSubmitQcDate': '2020-04-18', 'lastUpdatePostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Leptomeningeal Metastasis Overall survival', 'timeFrame': '36 months', 'description': 'Leptomeningeal Metastasis Overall survival defined as time from LM diagnosis to death due to any cause or last follow-up'}, {'measure': 'Neurological Progression Free Survival', 'timeFrame': '36 months', 'description': 'From the start of treatment until central nervous system metastase progression or death due to any cause'}, {'measure': 'The incidence of adverse reactions', 'timeFrame': '36 months', 'description': 'From date of first dose up to assessed from April 2020 to April 2023 (In accordance with the standard of CTCAE)'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate', 'timeFrame': '36 months', 'description': 'ORR, proportion of patients with a best overall response of complete response or partial response (CR+PR)'}, {'measure': 'Neurological assessment', 'timeFrame': '36 months', 'description': '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.'}, {'measure': 'progression-free survival', 'timeFrame': '36 months', 'description': 'Proportion of patients progression-free by investigator assessment per RECIST v1.1'}, {'measure': 'Overall survival', 'timeFrame': '36 months', 'description': 'defined as time from Non-Small Cell Lung Cancer diagnosis to death due to any cause or last follow-up'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Recombinant Human Endostatin', 'Non-Small Cell Lung Cancer with Leptomeningeal Metastasis'], 'conditions': ['Leptomeningeal Metastasis']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age over 18 years old\n2. Pathologically proven non-small cell lung cancer\n3. Karnofsky performance status ≥ 40\n4. 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 .\n5. No severe abnormal liver and kidney function;\n6. Patients have the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Evidence of bleeding diathesis or serious infection\n2. Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)\n3. Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT04356118', 'briefTitle': 'Efficacy and Safety of Recombinant Human Endostatin in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis', 'organization': {'class': 'OTHER', 'fullName': 'Hebei Medical University'}, 'officialTitle': 'Efficacy and Safety of Recombinant Human Endostatin in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis', 'orgStudyIdInfo': {'id': 'BH 005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endostatin Therapy for NSCLC of LM', 'description': 'Recombinant Human Endostatin + intrathcal methotrexate+Targeted drugs for non-small cell lung cancer\n\nRecombinant 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.\n\nintrathcal methotrexate :Intrathecal chemotherapy specified dose on specified days.\n\nTargeted drugs for non-small cell lung cancer:\n\nEGFR Mutation: Erlotinib，Afatinib，Osimertinib, et al. ALK ROS1 Mutation:Crizotinib,Ceritinib,Alectinib ,et al. BARF Mutation:Vemurafenib,et al. Other Mutation: other Targeted drugs .', 'interventionNames': ['Drug: Recombinant Human Endostatin', 'Drug: intrathcal methotrexate', 'Drug: Targeted drugs for non-small cell lung cancer']}], 'interventions': [{'name': 'Recombinant Human Endostatin', 'type': 'DRUG', 'otherNames': ['Endostatin'], 'description': '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.', 'armGroupLabels': ['Endostatin Therapy for NSCLC of LM']}, {'name': 'intrathcal methotrexate', 'type': 'DRUG', 'description': 'Intrathecal chemotherapy specified dose on specified days.', 'armGroupLabels': ['Endostatin Therapy for NSCLC of LM']}, {'name': 'Targeted drugs for non-small cell lung cancer', 'type': 'DRUG', 'description': '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 .', 'armGroupLabels': ['Endostatin Therapy for NSCLC of LM']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hui Bu', 'role': 'CONTACT', 'email': 'buhuimy1@163.com', 'phone': '86-13831106903'}], 'overallOfficials': [{'name': 'Hui Bu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Hospital of Hebei Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hui Bu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Study Principal Investigator', 'investigatorFullName': 'Hui Bu', 'investigatorAffiliation': 'Hebei Medical University'}}}}