Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2026-02-23 @ 3:02 PM
Study NCT ID:
NCT02862561
Status:
UNKNOWN
Last Update Posted:
2016-09-02
First Post:
2016-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-01', 'studyFirstSubmitDate': '2016-08-08', 'studyFirstSubmitQcDate': '2016-08-10', 'lastUpdatePostDateStruct': {'date': '2016-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '2 years'}, {'measure': 'Progress-free survival', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '2 years'}]}, 'conditionsModule': {'keywords': ['Precision Cell Immunotherapy', 'Chemotherapy', 'Advanced Malignancies'], 'conditions': ['Precision Cell Immunotherapy', 'Chemotherapy', 'Advanced Malignancies']}, 'descriptionModule': {'briefSummary': 'Objectives:\n\nTo evaluate the safety and effectiveness of cell therapy using Precision Cell Immunotherapy to treat Advanced Gastric Cancer.\n\nEligibility:\n\nIndividuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with Advanced Gastric Cancer.', 'detailedDescription': 'A total of 40 patients may be enrolled over a period of 1-2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18\\~65 years old, male or female;\n* Life expectancy≥6 months;\n* ECOG score: 0-3;\n* Advanced Malignancies (gastric cancer) were diagnosed by pathological or clinical physicians;\n* Enough venous channel, no other contraindications to the separation and collection of white blood cells;\n* Laboratory examination: white blood cell≥3 x 10\\*9/L, blood platelet count≥60 x 10\\*/L, hemoglobin≥85g/L; lymphocyte count≥15%, total bilirubin≤100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level;\n* Signed informed consent;\n* Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells transfusion.\n\nExclusion Criteria:\n\n* Expected Overall survival \\< 6 months;\n* Patients with uncontrolled hypertension (\\>160/95mmHg), unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\\> Class II, NYHA), or myocardial infarction within 6 months;\n* Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;\n* Other drugs, or other biological treatment,chemotherapy or radiotherapy are performed within a month;\n* Unable or unwilling to provide informed consent, or fail to comply with the test requirements.'}, 'identificationModule': {'nctId': 'NCT02862561', 'briefTitle': 'Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Gastric Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai International Medical Center'}, 'officialTitle': 'Clinical Study Using Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Gastric Cancer', 'orgStudyIdInfo': {'id': 'SIMC-20160105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Precision Cell Immunotherapy', 'description': 'Precision Cells combined with Chemotherapy treatment: Chemotherapy:\n\nonce a week with a total of six times before 60 days prior to the start of drawing blood. Precision Cells：once per 3 weeks with a total of three periods.', 'interventionNames': ['Drug: Chemotherapy', 'Biological: Precision Cells']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chemotherapy', 'description': 'Chemotherapy:\n\nonce a week with a total of six times before 60 days prior to the start of drawing blood.', 'interventionNames': ['Drug: Chemotherapy']}], 'interventions': [{'name': 'Chemotherapy', 'type': 'DRUG', 'description': 'Cisplatin：60mg/m2，5-FU：500mg/m2,Physiological saline 100ml:IV (in the vein) once a week with a total of six times.', 'armGroupLabels': ['Chemotherapy', 'Precision Cell Immunotherapy']}, {'name': 'Precision Cells', 'type': 'BIOLOGICAL', 'description': 'DC cell suspension (1×10\\*7 DC+physiological saline + 0.25% human bloodalbumin)1ml for each infusion, subcutaneous injection for each infusion, 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. Precision cells suspension (1-6×109 Precision cells + physiological saline + 0.25% human bloodalbumin) 300ml for each infusion, IV (in the vein) for each infusion, 3 cycles, each cycle received one infusions on day 21, 42, 63.', 'armGroupLabels': ['Precision Cell Immunotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201318', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Naiyan Han', 'role': 'CONTACT', 'email': 'naiyan.han@simcgroup.com', 'phone': '+86 (0) 182 1766 2469'}], 'facility': 'Shanghai International Medical Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Naiyan Han', 'role': 'CONTACT', 'email': 'naiyan.han@simcgroup.com', 'phone': '+86 21 6023 6666'}], 'overallOfficials': [{'name': 'Naiyan Han', 'role': 'STUDY_CHAIR', 'affiliation': 'Shanghai International Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai International Medical Center', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}