Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-27 @ 10:39 PM
Study NCT ID:
NCT01821495
Status:
UNKNOWN
Last Update Posted:
2013-04-12
First Post:
2013-03-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of DC-CIK to Treat NPC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-04-11', 'studyFirstSubmitDate': '2013-03-27', 'studyFirstSubmitQcDate': '2013-03-29', 'lastUpdatePostDateStruct': {'date': '2013-04-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Laboratory findings', 'timeFrame': '1 month'}], 'primaryOutcomes': [{'measure': 'progression-free survival(PFS)', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'overall survival(OS)', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['NPC,DC-CIK'], 'conditions': ['Nasopharyngeal Carcinoma']}, 'descriptionModule': {'briefSummary': 'Concurrent of radiotherapy and chemotherapy is the main treatment method for patients with nasopharyngeal carcinoma (NPC). However, Relapse remains the major cause of treatment failure. A series of studies reported that dendritic and cytokine-induced killer cells (DC-CIK) have a broad anti-tumor spectrum. We suppose that DC-CIK will improve the prognosis of NPC. In this study, the patients with NPC will be treated with DC-CIK cells after concurrent of chemotherapy and radiotherapy. The purpose of this study is to evaluate the efficacy of DC-CIK for NPC.', 'detailedDescription': 'About 60 patients with staging Ⅱ-Ⅲ of NPC, after accepting concurrent radiotherapy and chemotherapy, will be randomly divided into group A (receive DC-CIK treatment) or group B (just regularly follow up), and the randomize ratio will be 1:1. Patients in group A will receive 2-3 cycles of DC-CIK cells treatment (every 4 weeks). Patients in group B will have no anti-tumor therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with staging Ⅱ-Ⅲ of NPC;\n2. Patients who had completed concurrent of radiotherapy and chemotherapy;\n3. Patients who have a life expectancy of at least 12 weeks;\n4. Eastern Cooperative Oncology Group (ECOG) performance status was 0-1;\n5. The bone marrow functioned normally (WBC \\> 4.0×109/L, Hb \\> 120 g/L, PLT \\> 100×109/L);\n6. The ECG results were normal, and the liver and kidney were functional.\n\nExclusion Criteria:\n\n1. Patients who had distant metastases by imaging studies;\n2. Patients with uncontrolled infection; underlying disease that was severe or life-threatening;\n3. Patients who were pregnant or lactating;\n4. ECOG perform status ≥ 2;\n5. Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment.'}, 'identificationModule': {'nctId': 'NCT01821495', 'briefTitle': 'Study of DC-CIK to Treat NPC', 'organization': {'class': 'OTHER', 'fullName': 'Guangxi Medical University'}, 'officialTitle': 'A Randomized Controlled Study of Dendritic and Cytokine-induced Killer Cells (DC-CIK) Treatment in Patients With Staging Ⅱ-Ⅲ of Nasopharyngeal Carcinoma', 'orgStudyIdInfo': {'id': 'NPC-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'B', 'description': 'After accepting concurrent radiotherapy and chemotherapy, patients will just regularly follow up.'}, {'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'After accepting concurrent radiotherapy and chemotherapy, patients will receive 3 cycles of Dendritic and Cytokine-induced Killer Cells (DC-CIK)treatment.', 'interventionNames': ['Biological: DC-CIK', 'Biological: Dendritic and Cytokine-induced Killer Cells']}], 'interventions': [{'name': 'DC-CIK', 'type': 'BIOLOGICAL', 'armGroupLabels': ['A']}, {'name': 'Dendritic and Cytokine-induced Killer Cells', 'type': 'BIOLOGICAL', 'otherNames': ['DC-CIK'], 'description': 'Concurrent of radiotherapy and chemotherapy plus 3 cycles of Dendritic and Cytokine-induced Killer Cells(DC-CIK) treatment', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '530000', 'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'contacts': [{'name': 'Hanfeng Liu, Master', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Guangxi Medical University', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}], 'centralContacts': [{'name': 'Weiliang Sun, M.D.', 'role': 'CONTACT', 'email': 'swl20012002@sohu.com', 'phone': '86-771-3277289'}], 'overallOfficials': [{'name': 'Hanfeng Liu', 'role': 'STUDY_CHAIR', 'affiliation': 'Guangxi Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangxi Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'investigator', 'investigatorFullName': 'Weiliang Sun', 'investigatorAffiliation': 'Guangxi Medical University'}}}}