Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT01637805
Status:
UNKNOWN
Last Update Posted:
2016-03-08
First Post:
2012-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Safety and Preliminary Efficacy of AAV-DC-CTL Treatment in Stage IV Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-07', 'studyFirstSubmitDate': '2012-07-03', 'studyFirstSubmitQcDate': '2012-07-10', 'lastUpdatePostDateStruct': {'date': '2016-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate', 'timeFrame': 'Up to 12 months', 'description': 'CR + PR = ORR'}]}, 'conditionsModule': {'conditions': ['Stage IV Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the clinical safety and preliminary efficacy of antigen-specific cytotoxic T lymphocytes induced by dendritic cells infected by recombinant adeno-associated virus with CEA gene in the treatment of stage IV gastric cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sex: male or female\n* Age: from 18 to 80 years\n* Histology: gastric cancer\n* Clinical stage: stage IV\n* Karnofsky performance status: more than 50%\n* Expected survival: more than 2 months\n* Sex: male or female\n* Laboratory tests results 7 days before the start of treatment:\n\n * White blood cells: more than 3.0 × 109/L\n * Platelets: more than 100 × 109/L\n * Neutrophils: more than 1.5 × 109/L\n * Hemoglobin: more than 80g/L\n * Serum glutamate pyruvate transaminase: less than 2.5 folds of the upper normal limit (ULN)\n * Serum glutamic-oxal (o) acetic transaminase: less than 2.5 × ULN\n * Serum bilirubin: less than 1.25 × ULN\n * Serum creatinine: less than 1.25 × ULN\n* Pregnancy test: the test of women of child-bearing period must be negative 7 days before the start of treatment\n* Contraception: male and female subjects of child-bearing period must adopt a reliable method of contraception before entry into this study until 30 days after stopping this study\n* Informed consent: subject must have the ability to understand and voluntarily sign a written informed consent\n\nExclusion Criteria:\n\n* History of neoplasms: other neoplasms\n* Medical history: mental disease, or congestive heart failure, or severe coronary artery disease, or cardiac arrhythmias, or concomitant corticosteroid therapy\n* Metastasis: clinical symptoms of brain metastasis\n* Other clinical trial: the subject received other clinical trial before this study\n* Laboratory tests: the serum test of human immunodeficiency virus, or hepatitis B virus, or hepatitis C virus was positive\n* Woman: pregnant or lactating women\n* Compliance: poor compliance'}, 'identificationModule': {'nctId': 'NCT01637805', 'acronym': 'AAV-DC-CTL', 'briefTitle': 'Clinical Safety and Preliminary Efficacy of AAV-DC-CTL Treatment in Stage IV Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University Cancer Institute and Hospital'}, 'officialTitle': 'Phase 1 Study of Antigen-specific Cytotoxic T Lymphocytes Induced by Dendritic Cells Infected by Recombinant Adeno-associated Virus With CEA Gene in Stage IV Gastric Cancer', 'orgStudyIdInfo': {'id': 'CIH-ZRP-201205001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AAV-DC-CTL', 'interventionNames': ['Biological: Antigen-specific cytotoxic T lymphocytes induced by dendritic cells infected by recombinant adeno-associated virus with CEA gene']}], 'interventions': [{'name': 'Antigen-specific cytotoxic T lymphocytes induced by dendritic cells infected by recombinant adeno-associated virus with CEA gene', 'type': 'BIOLOGICAL', 'description': 'AAV-DC-CTL: Intravenous infusion, 1×109 cells, day 14; one cycle every month; at least one cycle', 'armGroupLabels': ['AAV-DC-CTL']}]}, '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'}}}}