Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-01-05 @ 6:01 PM
Study NCT ID:
NCT01757366
Status:
UNKNOWN
Last Update Posted:
2014-04-01
First Post:
2012-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Ginsenoside Rg3 in Combination With First-line Chemotherapy in Advanced Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C097367', 'term': 'ginsenoside Rg3'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-03-30', 'studyFirstSubmitDate': '2012-12-21', 'studyFirstSubmitQcDate': '2012-12-21', 'lastUpdatePostDateStruct': {'date': '2014-04-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': '1 years'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': '1 year'}, {'measure': 'Overall Survival (OS)', 'timeFrame': '3 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Self Efficacy']}, 'descriptionModule': {'briefSummary': 'Safety and Efficacy of Ginsenoside Rg3 in Combination with First-line Chemotherapy in Advanced Gastric Cancer.The purpose of this study is to assess the safety of Ginsenoside Rg3 in advanced gastric cancer, and whether it improves the efficacy of first-line chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed informed consent form\n2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;\n3. Histologically or cytologically confirmed gastric cancer;\n4. At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors )\n5. Life expectancy of at least 3 months;\n\nExclusion Criteria:\n\n1. Received any prior treatment including Ginsenoside Rg3;\n2. Active or uncontrolled infection;\n3. Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;\n4. Pregnant or lactating women.'}, 'identificationModule': {'nctId': 'NCT01757366', 'briefTitle': 'Safety and Efficacy of Ginsenoside Rg3 in Combination With First-line Chemotherapy in Advanced Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hebei Tumor Hospital'}, 'officialTitle': 'Safety and Efficacy of Ginsenoside Rg3 in Combination With First-line Chemotherapy in Advanced Gastric Cancer', 'orgStudyIdInfo': {'id': 'HBTH102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental', 'description': 'Ginsenoside Rg3 plus First-line Chemotherapy', 'interventionNames': ['Drug: Ginsenoside Rg3 plus First-line Chemotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator', 'description': 'First-line Chemotherapy', 'interventionNames': ['Drug: First-line Chemotherapy']}], 'interventions': [{'name': 'Ginsenoside Rg3 plus First-line Chemotherapy', 'type': 'DRUG', 'description': 'Ginsenoside Rg3 20mg 2/day po,patients will receive Ginsenoside Rg3 until progression\n\nXELOX(oxaliplatin 130mg/m2 iv d1;capecitabine 1000mg/m2 po bid d1-14)every 3 weeks for 4 cycles followed by capecitabine until progression', 'armGroupLabels': ['experimental']}, {'name': 'First-line Chemotherapy', 'type': 'DRUG', 'description': 'XELOX(oxaliplatin 130mg/m2 iv d1;capecitabine 1000mg/m2 po bid d1-14)every 3 weeks for 4 cycles followed by capecitabine until progression', 'armGroupLabels': ['Active Comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050011', 'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Baoen Shan', 'role': 'CONTACT', 'email': '15931166600@126.com', 'phone': '13803343508'}, {'name': 'Wei Liu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hebei Tumor Hospital', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}], 'centralContacts': [{'name': 'Baoen Shan', 'role': 'CONTACT', 'email': '15931166600@126.com', 'phone': '15931166600'}], 'overallOfficials': [{'name': 'Wei Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hebei Tumor Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hebei Tumor Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}