Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-23 @ 9:22 PM
Study NCT ID:
NCT02956551
Status:
UNKNOWN
Last Update Posted:
2018-05-31
First Post:
2016-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalized DC Vaccine for Lung Cancer
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': 'C000706173', 'term': 'lentiviral minigene vaccine of COVID-19 coronavirus'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-29', 'studyFirstSubmitDate': '2016-11-01', 'studyFirstSubmitQcDate': '2016-11-03', 'lastUpdatePostDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': '3 months after the last administration of cells', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0'}], 'secondaryOutcomes': [{'measure': 'objective response rate', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Number of participants with objective responses as assayed by RECIST 1.1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['advanced non-small cell lung cancer', 'cell based therapy', 'safety', 'clinical efficacy'], 'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'descriptionModule': {'briefSummary': 'The study is aimed to the test the efficacy and safety of neoantigen-primed dendritic cell (DC) cell vaccine therapy for refractory non-small cell lung cancer.', 'detailedDescription': "Patients with pathological confirmed non-small cell lung cancer with no standard treatment are enrolled. The patients fails in previous at least 2 lines of chemotherapy and 1 line of targeted therapy where applicable. This is a prospective exploratory trial. Patients' rebiopsy tumor tissues are subsequent to whole exosome sequencing and possible neoantigens are identified. DC is in vitro primed with synthesized peptides. Both adverse events and responses are recorded."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pathologically confirmed non-small cell lung cancer\n* failed in previous standard chemotherapy and targeted therapy\n* anticipated life time \\> 3month\n* Karnofsky performance status 0-1\n* rehabilitate from previous therapy\n* adequate organ functions\n\nExclusion Criteria:\n\n* mixed histological types\n* tumor emergency\n* abnormal coagulation condition\n* contagious diseases, such as hepatitis B virus, hepatitis C virus, human immunodefficiency virus, tuberculosis infection\n* concomitant tumors\n* immunological co-morbidities'}, 'identificationModule': {'nctId': 'NCT02956551', 'acronym': 'SKLB1608', 'briefTitle': 'Personalized DC Vaccine for Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sichuan University'}, 'officialTitle': 'Neoantigen-primed DC Vaccine Therapy for Refractory Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'SKLB1608'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cell_therapy', 'description': 'tumor neoantigen primed DC vaccines are administrated, 2-week interval, totally 5 times', 'interventionNames': ['Biological: DC vaccine']}], 'interventions': [{'name': 'DC vaccine', 'type': 'BIOLOGICAL', 'description': 'subcutaneous administration', 'armGroupLabels': ['cell_therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610000', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhen-Yu Ding, Prof', 'role': 'CONTACT', 'email': 'dingzhenyu@scu.edu.cn', 'phone': '00862885423571'}], 'facility': 'China West Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Zhen-Yu Ding, Prof', 'role': 'CONTACT', 'email': 'dingzhenyu@scu.edu.cn'}], 'overallOfficials': [{'name': 'Zhen-Yu Ding, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sichuan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sichuan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhen-Yu Ding', 'investigatorAffiliation': 'Sichuan University'}}}}