Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-02-18 @ 1:35 PM
Study NCT ID:
NCT02603003
Status:
COMPLETED
Last Update Posted:
2019-09-20
First Post:
2015-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the"Fuzheng" Therapy of TCM to Improve the Survival Quality of Early-stage NSCLC by Intervening the CTCs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D009360', 'term': 'Neoplastic Cells, Circulating'}], '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'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C544151', 'term': 'jinfukang'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000077235', 'term': 'Vinorelbine'}, {'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'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': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 218}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-18', 'studyFirstSubmitDate': '2015-10-21', 'studyFirstSubmitQcDate': '2015-11-10', 'lastUpdatePostDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival', 'timeFrame': 'The progression disease is assessed based on CT or PET-CT every six months from date of randomization and the endpoints is the date of first documented progression or date of death due to lung cancer,assessed up to Two years.', 'description': 'It is decided by a doctor via the clinical examinations'}], 'secondaryOutcomes': [{'measure': 'Circulating Tumor Cell', 'timeFrame': '24months', 'description': 'It is decided by a doctor via the clinical examinations'}, {'measure': 'Overall survival', 'timeFrame': 'Two years', 'description': 'It is decided by a doctor via the clinical examinations'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Circulating tumor cells(CTCs)', 'Traditional Chinese Medicine(TCM)', 'Myeloid-derived suppressor cells(MDSCs)'], 'conditions': ['Non-small Cell Lung Cancer(NSCLC)']}, 'descriptionModule': {'briefSummary': "Metastasis is the leading cause of death in patients with lung cancer, and circulating tumor cells(CTCs) play a key role in the process of distant metastasis. The investigators' study will elaborate the clinical significance of CTCs intervented by Traditional Chinese Medicine(TCM) in lung cancer from the diagnosis and clinical staging,metastasis and recurrence, individual treatment and prognosis and so on, in order to provide a new direction for the treatment of lung cancer.", 'detailedDescription': "Metastasis is the leading cause of death in patients with lung cancer, and circulating tumor cells play a key role in the process of distant metastasis.In recent years, research results have shown that CTCs may become a emerging marker and new target in the treatment of lung cancer. The investigators' study will elaborate the clinical significance of CTCs intervented by TCM in lung cancer from the diagnosis and clinical staging,metastasis and recurrence, individual treatment and prognosis and so on, in order to provide a new direction for the treatment of lung cancer."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Complete resection was accepted in IIa \\~ Ⅲa stage, and the pathological changes could confirmed as non small cell lung cancer patients;\n2. Patients receiving chemotherapy for the first time in 6 weeks after surgery;\n3. Age from 18 Years to 70 Years;\n4. The liver and renal function were normal,and no other disease.\n5. Patients compliance is good ang can understand the situation of this study and signed informed consent\n\nExclusion Criteria:\n\n1. Patients without clear pathological diagnosis;\n2. The expected survival period is morn than 6 months;\n3. Patients with serious diseases such as heart, liver, kidney and hematopoietic system;\n4. Patients with pregnancy or lactation;\n5. Persons with a history of less control.'}, 'identificationModule': {'nctId': 'NCT02603003', 'acronym': 'CTC-TCM-FZ', 'briefTitle': 'the"Fuzheng" Therapy of TCM to Improve the Survival Quality of Early-stage NSCLC by Intervening the CTCs', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai University of Traditional Chinese Medicine'}, 'officialTitle': 'A Study on the"Fuzheng"Therapy Promoted Immune Reconstitution to Improve the Survival of Early-stage Lung Cancer After Surgical Operation', 'orgStudyIdInfo': {'id': 'Longhua Hospital'}, 'secondaryIdInfos': [{'id': 'TJH20151021', 'type': 'REGISTRY', 'domain': 'TIAN Jianhui'}, {'id': 'LB20151106', 'type': 'REGISTRY', 'domain': 'Robin'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Cisplatin', 'description': 'Cisplatin', 'interventionNames': ['Drug: Cisplatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Pemetrexed', 'description': 'Pemetrexed', 'interventionNames': ['Drug: Pemetrexed']}, {'type': 'EXPERIMENTAL', 'label': 'Jinfukang', 'description': 'Jinfukang', 'interventionNames': ['Drug: JinFuKang', 'Drug: Cisplatin', 'Drug: Pemetrexed']}], 'interventions': [{'name': 'JinFuKang', 'type': 'DRUG', 'otherNames': ['Jin Fukang oral liquid'], 'description': 'po.tid.30ml', 'armGroupLabels': ['Jinfukang']}, {'name': 'Cisplatin', 'type': 'DRUG', 'otherNames': ['Navelbine'], 'description': "According to the individual patient's condition", 'armGroupLabels': ['Cisplatin', 'Jinfukang']}, {'name': 'Pemetrexed', 'type': 'DRUG', 'otherNames': ['Pemetrexeddisodium for Injection'], 'description': "According to the individual patient's condition", 'armGroupLabels': ['Jinfukang', 'Pemetrexed']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai University of Traditional Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'jianhuitian', 'investigatorAffiliation': 'Shanghai University of Traditional Chinese Medicine'}}}}