Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-31 @ 10:25 AM
Study NCT ID:
NCT02657460
Status:
UNKNOWN
Last Update Posted:
2019-02-26
First Post:
2016-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of Tumor Cell-derived Microparticles Packaging Chemotherapeutic Drugs to Treat Malignant Pleural Effusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016066', 'term': 'Pleural Effusion, Malignant'}], 'ancestors': [{'id': 'D010997', 'term': 'Pleural Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010996', 'term': 'Pleural Effusion'}, {'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-24', 'studyFirstSubmitDate': '2016-01-11', 'studyFirstSubmitQcDate': '2016-01-13', 'lastUpdatePostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pleural effusions volume', 'timeFrame': 'four weeks'}], 'secondaryOutcomes': [{'measure': 'Rivalta Test of pleural effusions', 'timeFrame': 'four weeks'}, {'measure': 'total protein level of pleural effusions', 'timeFrame': 'four weeks'}, {'measure': 'total karyocytes count of pleural effusions', 'timeFrame': 'four weeks'}, {'measure': 'lactic dehydrogenase level of pleural effusions', 'timeFrame': 'four weeks'}, {'measure': 'adenosine deaminase level of pleural effusions', 'timeFrame': 'four weeks'}, {'measure': 'the cytology test of pleural effusions', 'timeFrame': 'four weeks'}, {'measure': 'Karnofsky index', 'timeFrame': 'four weeks'}, {'measure': 'survival time', 'timeFrame': 'six month'}, {'measure': 'carcino embryonie antigen level in microgramme/L in serum', 'timeFrame': 'four weeks'}, {'measure': 'CYFRA21-1 level in ng/mL in serum', 'timeFrame': 'four weeks'}, {'measure': 'neuron specific annuals level in microgramme/L in serum', 'timeFrame': 'four weeks'}, {'measure': 'squamous cell carcinoma antigen level in ng/mL in serum', 'timeFrame': 'four weeks'}, {'measure': 'carcino embryonie antigen level in microgramme/L in pleural effusions', 'timeFrame': 'four weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chemotherapy', 'microparticle', 'malignant pleural effusion'], 'conditions': ['Malignant Pleural Effusion']}, 'descriptionModule': {'briefSummary': 'The study is to investigate the anticancer effect and the related immunological mechanism of MTX-ATMPs in the treatment of malignant pleural effusion.', 'detailedDescription': 'Malignant pleural effusion(MPE) as a common complication of advanced lung cancer is lack of efficient treatments. The investigators have successfully produced tumor cell-derived microparticles packaging chemotherapy drugs and confirmed that this new integrative targeted biochemotherapy treatment could effectively restrain tumor growth at cellular and animal levels.This new method could control tumor growth in vivo effectively and induced pleural adhesion in the early clinical study. So the investigators attempt to explore the anticancer effect and related immune regulation mechanism of methotrexate-autologous tumor derived microparticles (MTX-ATMPs) in MPE treatment. The tumor cells in the malignant pleural effusion are prepared by screening, then MTX-ATMPs are made. Participants enrolled are randomly assigned to experimental and control group, each of them is injected with the prepared drug once in two days until the malignant pleural effusion are disappeared or the treatment cycle has been six times. During or after the whole treatment, reactions to each treatment of the participants are carefully followed up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The diagnosis of lung cancer and malignant pleural effusion was confirmed by pathology and / or pleural fluid cytology;\n2. The routine surgery or systemic radio/chemotherapy was ineffective, the MPE relapsed, or routine treatment therapy was given up by self-causes;\n3. stable vital sign with KPS(Karnofsky Performance Status) index more than 60;\n4. 18-70 years old;\n5. normal haematopoietic function of bone marrow, no hemorrhagic tendency, blood routine test: HGB\\>=100g/L, WBC\\>4.0\\*10\\^9/L, PLT\\>80\\*10\\^9/L, serum ALT, AST within 2 times upper limit of normal, BUN within 1.5 time upper limit of normal, creatinine within normal range, normal EKG;\n6. agreed to participate in the study and sign an informed consent;\n7. without other severe comorbidities.\n\nExclusion Criteria:\n\n1. lactating or pregnant patients;\n2. allergy to multiple drugs;\n3. with other severe comorbidities or psychological diseases;\n4. severe infection;\n5. participation in other clinical trials within the recent three months.'}, 'identificationModule': {'nctId': 'NCT02657460', 'briefTitle': 'Clinical Trial of Tumor Cell-derived Microparticles Packaging Chemotherapeutic Drugs to Treat Malignant Pleural Effusion', 'organization': {'class': 'OTHER', 'fullName': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, 'officialTitle': 'Clinical Trial of Tumor Cell-derived Microparticles Packaging Chemotherapeutic Drugs to Treat Malignant Pleural Effusion', 'orgStudyIdInfo': {'id': 'v1.4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MTX-ATMPs', 'description': 'methotrexate-autologous tumor derived microparticles', 'interventionNames': ['Biological: tumor derived microparticles']}, {'type': 'SHAM_COMPARATOR', 'label': 'cisplatin', 'description': 'Cisplatin is a traditional treatment for lung cancer', 'interventionNames': ['Drug: cisplatin']}], 'interventions': [{'name': 'tumor derived microparticles', 'type': 'BIOLOGICAL', 'description': 'The main difference between the two treatment groups is the biological coat, which is tumor derived microparticles.', 'armGroupLabels': ['MTX-ATMPs']}, {'name': 'cisplatin', 'type': 'DRUG', 'otherNames': ['cisplatinum'], 'description': 'cisplatin is a traditional drug for lung cancer', 'armGroupLabels': ['cisplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yang Jin, doctor', 'role': 'CONTACT', 'email': 'whuhjy@sina.com', 'phone': '+86 13554361146'}], 'facility': 'Union Hospital, Tongji Medical College, Huazhong University of Science & Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Feng Wu, Master', 'role': 'CONTACT', 'email': 'wufengxiehe@163.com', 'phone': '086-13476080943'}], 'overallOfficials': [{'name': 'Yang Jin, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science & Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no plan to share IPD now'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yang Jin', 'investigatorAffiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}}}}