Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-24 @ 6:49 PM
Study NCT ID:
NCT04258657
Status:
UNKNOWN
Last Update Posted:
2020-02-06
First Post:
2020-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neoadjuvant Chomotherapy With Paclitaxel-albumin and S-1 for Advanced 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C079198', 'term': 'S 1 (combination)'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-05', 'studyFirstSubmitDate': '2020-02-05', 'studyFirstSubmitQcDate': '2020-02-05', 'lastUpdatePostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DFS', 'timeFrame': '3-year', 'description': 'disease free survival'}], 'secondaryOutcomes': [{'measure': 'ORR', 'timeFrame': '3-year', 'description': 'objective response rate'}, {'measure': 'OS', 'timeFrame': '3-year', 'description': 'overall survival'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'This is a interventional clinical trial to assess the efficacy and safety of combinational therapy of paclitaxel-albumin and S-1 for the neoadjuvant chemotherapy of advanced gastric cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. pathologically diagnosed gastric adenocarcinoma\n2. Type II and III esophageal-gastric-junction malignancy\n3. AJCC stage II-III\n4. No contraindications for surgery, radical resection can be expected\n5. KPS\\>60; ECOG score:0-2\n6. Expactant survival period\\>6 months\n7. Age 20\\~75\n8. No other major health issues\n9. Lab results within 7 days before inclusion must satisfy:\n\n 1. neutrophil≥1.5×109/L\n 2. PLT≥100×109/L\n 3. hemogloblin≥90g/L\n 4. ALT,AST\\<1.5 upper limit\n 5. Tbil≤1.0×UNL\n 6. serum creatinine\\<1.5×UNL\n 7. PT-INR/PTT\\<1.7 upper limit\n10. with measurable lesion according to RECIST1.1 criteria\n11. with consent\n12. co-operative\n\nExclusion Criteria:\n\n1. with other major health issue\n2. allergic to relevant drugs\n3. experienced any other drug therapy with 4 weeks before inclusion\n4. experienced any drug therapy for gastric cancer at anytime\n5. diagnosed with any other malignancy within the past 5 years\n6. women at child-bearing age; pregnant or breast-feeding women\n7. with severe heart disease\n8. with upper GI digestion or disrupted absorption\n9. with peripheral neural disease\n10. with transplated organs or organs having been resected for transplantation\n11. known DPD deficiency\n12. with uncontrolled infection'}, 'identificationModule': {'nctId': 'NCT04258657', 'briefTitle': 'Neoadjuvant Chomotherapy With Paclitaxel-albumin and S-1 for Advanced Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Friendship Hospital'}, 'officialTitle': 'Neoadjuvant Chomotherapy With Paclitaxel-albumin and S-1 for Advanced Gastric Cancer', 'orgStudyIdInfo': {'id': 'BFH-GCCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paclitaxel-albumin and S-1', 'interventionNames': ['Drug: paclitaxel-albumin and S-1']}], 'interventions': [{'name': 'paclitaxel-albumin and S-1', 'type': 'DRUG', 'description': 'neoadjuvant chomotherapy with paclitaxel-albumin and S-1 for advanced gastric cancer', 'armGroupLabels': ['Paclitaxel-albumin and S-1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Zhongtao Zhang', 'role': 'CONTACT', 'email': 'zhongtao.z@139.com', 'phone': '8618811792819', 'phoneExt': '8618811792819'}], 'facility': 'Zhongtao Zhang', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Zhongtao Zhang', 'role': 'CONTACT', 'email': 'zhongtao.z@139.com', 'phone': '8618811792819', 'phoneExt': '8618811792819'}], 'overallOfficials': [{'name': 'Wei Deng', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beijing Friendship Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhongtao Zhang', 'investigatorAffiliation': 'Beijing Friendship Hospital'}}}}