Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-02-28 @ 5:31 AM
Study NCT ID:
NCT02497118
Status:
COMPLETED
Last Update Posted:
2015-07-14
First Post:
2015-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recombinant Human Endostatin Combined With NP in Neoadjuvant Chemotherapy of Stage ⅢA NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D043169', 'term': 'Endostatins'}, {'id': 'C522911', 'term': 'endostar protein'}, {'id': 'D000077235', 'term': 'Vinorelbine'}, {'id': 'D002945', 'term': 'Cisplatin'}], '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'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-13', 'studyFirstSubmitDate': '2015-07-05', 'studyFirstSubmitQcDate': '2015-07-13', 'lastUpdatePostDateStruct': {'date': '2015-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor Regression Rate', 'timeFrame': '3 months', 'description': 'Target lesion size reduction ratio'}], 'secondaryOutcomes': [{'measure': 'Disease free survival is defined as the time from randomization to disease recurrence or death which comes first.', 'timeFrame': '5 years'}, {'measure': 'Overall Survival', 'timeFrame': '5 years', 'description': 'the time from randomization to death.'}, {'measure': 'Clinical Benefit Rate', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['lung cancer Anti angiogenesis therapy survival'], 'conditions': ['Non Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '27566586', 'type': 'DERIVED', 'citation': 'Zhao X, Su Y, You J, Gong L, Zhang Z, Wang M, Zhao Z, Zhang Z, Li X, Wang C. Combining antiangiogenic therapy with neoadjuvant chemotherapy increases treatment efficacy in stage IIIA (N2) non-small cell lung cancer without increasing adverse effects. Oncotarget. 2016 Sep 20;7(38):62619-62626. doi: 10.18632/oncotarget.11547.'}]}, 'descriptionModule': {'briefSummary': 'This study mainly to observe the anti angiogenic drugs Endostatin (Endostar) combined with vinorelbine and Cisplatin (NP) as neoadjuvant therapy in patients with non small cell lung cancer clinical efficiency and safety. Through anti angiogenesis therapy combined with neoadjuvant chemotherapy improve the treatment of neoadjuvant therapy in tumor response rate and the rate of resection, At the same time, the study before and after the anti angiogenesis therapy in patients with peripheral blood circulation endothelial cells(CECs), levels of Endothelial progenitor cells（EPC）, micro vascular density（MVD） and vascular endothelial growth factor(VEGF) expression level, to understanding the correlation between the clinical efficacy of anti angiogenesis therapy combined with chemotherapy and the change of all these markers. In order to find the reference basis for the prediction of the effect of curative effect. The changes of blood volume, blood flow and vascular permeability of the lung cancer before and after treatment with CT perfusion imaging are studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The pathology proved to be non small cell lung cancer (must be histologically).\n* At present, the patients with ⅢA stage (N2) were evaluated by the assistant examination;\n* The patients were evaluated by imaging, laboratory examination and other examination;\n* Without chemotherapy or anti angiogenic therapy;\n* There can be measured lesions\n* Informed consent.\n\nExclusion Criteria:\n\n* Pregnant, lactating women, or patients with fertility but did not take contraceptive measures.\n* Severe infection.\n* Severe heart disease.Neuropsychiatric disorders, which is not easy to control.\n* Severe diabetes.\n* There is obvious bleeding tendency.\n* The 5 years history of other tumors'}, 'identificationModule': {'nctId': 'NCT02497118', 'briefTitle': 'Recombinant Human Endostatin Combined With NP in Neoadjuvant Chemotherapy of Stage ⅢA NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University Cancer Institute and Hospital'}, 'officialTitle': 'Clinical Study of Recombinant Human Endostatin Combined With NP Chemotherapy in the Treatment of Stage ⅢA Non Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'TMUCIH-ENDU-S001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endostatin plus NP', 'description': 'drug:Endostatins Intravenous drip， 7.5mg/m\\^2, d1-14 drug:vinorelbine Intravenous drip 25mg/m\\^2,IV, d1, d8; drug:Cisplatin，75mg/m\\^2 Intravenous drip,divide into d1-3 for 2 cycles', 'interventionNames': ['Drug: Endostatin', 'Drug: Vinorelbine', 'Drug: Cisplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NP neoadjuvant chemotherapy', 'description': 'drug:vinorelbine Intravenous drip 25mg/m\\^2,IV, d1, d8; drug:Cisplatin，75mg/m\\^2 Intravenous drip,divide into d1-3 for 2 cycles', 'interventionNames': ['Drug: Vinorelbine', 'Drug: Cisplatin']}], 'interventions': [{'name': 'Endostatin', 'type': 'DRUG', 'otherNames': ['Endostar'], 'description': 'Endostatin,7.5mg/m\\^2,intravenous, d1-14;', 'armGroupLabels': ['Endostatin plus NP']}, {'name': 'Vinorelbine', 'type': 'DRUG', 'description': 'vinorelbine,25mg/m\\^2,intravenous, d1, d8;', 'armGroupLabels': ['Endostatin plus NP', 'NP neoadjuvant chemotherapy']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'Cisplatin，75mg/m\\^2 intravenous,divide into d1-3', 'armGroupLabels': ['Endostatin plus NP', 'NP neoadjuvant chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300060', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Medical University Cancer Institute and Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University Cancer Institute and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}