Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2025-12-30 @ 6:49 PM
Study NCT ID:
NCT03801668
Status:
UNKNOWN
Last Update Posted:
2022-01-04
First Post:
2019-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Albumin-bound Paclitaxel Plus S-1 Versus SOX as First-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma
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': 'D000068196', 'term': 'Albumin-Bound Paclitaxel'}, {'id': 'C079198', 'term': 'S 1 (combination)'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}], 'ancestors': [{'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 294}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-03', 'studyFirstSubmitDate': '2019-01-07', 'studyFirstSubmitQcDate': '2019-01-10', 'lastUpdatePostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'up to 3 years', 'description': 'PFS is defined as time from the start of treatment to progression of disease or death.'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'up to 3 years', 'description': 'The rate of participants that achieve either a complete response (CR) or a partial response (PR).'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'up to 3 years', 'description': 'Overall survival is defined as time from the start of treatment until death due to any reason.'}, {'measure': 'Safety as measured by number and grade of adverse events', 'timeFrame': 'up to 3 years', 'description': 'Summary adverse events according to NCI-CTCAE 4.03'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastric Cancer', 'Albumin-bound Paclitaxel'], 'conditions': ['Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '35983025', 'type': 'DERIVED', 'citation': 'Dai YH, Yu XJ, Xu HT, Zhuang L, Zhang MS, Zou YM, Fu Q, Qiu H, Yuan XL. Nab-paclitaxel plus S-1 versus oxaliplatin plus S-1 as first-line treatment in advanced gastric cancer: results of a multicenter, randomized, phase III trial (GAPSO study). Ther Adv Med Oncol. 2022 Aug 12;14:17588359221118020. doi: 10.1177/17588359221118020. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'It is a trial to compare the efficacy and safety of Albumin-bound Paclitaxel plus S-1 versus Oxaliplatin plus S-1 (SOX) as first-line treatment in advanced or recurrent gastric adenocarcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age of 18-75 years;\n2. Cytological or histological diagnosis of recurrent or metastatic gastric adenocarcinoma;\n3. At least one measurable lesion as defined by RECIST 1.1 criteria;\n4. ECOG performance status of 0-1;\n5. Estimated life expectancy of at least 3 months;\n6. Left ventricular ejection fraction (LVEF) ≥ 50%;\n7. Bone marrow function: absolute neutrophil count(ANC) ≥1.5×109 /L, platelet count(PLT) ≥90×109 /L, hemoglobin(HB) ≥90 g/L;\n8. Liver and kidney function: Creatinine(Cr)≤1.5 x upper limit of normal range(ULN); alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤2.5 x upper limit of normal range (ULN), or ≤5 x upper limit of normal range (ULN)when with hepatic metastases，total bilirubin (TBIL)≤1.5 x upper limit of normal range (ULN), or≤2.5 x upper limit of normal range (ULN) when with Gilbert's syndrome;\n9. Not be breast-feeding; men and women of reproductive age are willing to take reliable contraceptive measures during the study;\n10. Able and willing to comply with the study plans in this protocol and sign the informed consent;\n\nExclusion Criteria:\n\n1. Have received chemotherapy before；patients that received neoadjuvant or adjuvant chemotherapy are eligible provided the treatment is completed\\>6 months prior to first recurrence or metastasis;\n2. HER-2 positive;\n3. Patients with symptomatic brain metastases;\n4. II-IV peripheral neuropathy \\[NCI-CTCAE 4.03\\];\n5. Anti-HCV antibody positive and HCV-RNA positive; anti-HBV antibody positive with active hepatitis ; anti-HIV antibody positive;\n6. Patients with serious systemic infection or other diseases;\n7. Allergic to the chemotherapy drugs or the materials in this study;\n8. Patients with gastrointestinal bleeding that need clinical intervention;\n9. Patients with digestive tract obstruction or oral nutrition difficulty;\n10. Have a second malignancy within 5 years prior to registration except for cured carcinoma in situ of cervix uteri, non-melanoma skin cancer;\n11. Have participated in other clinical trials within 28 days prior to the first dose of this study;\n12. Contraindications to chemotherapy;\n13. Patients that researcher consider cannot sign informed consent or complete the study plan due to medical science factor, social factor or psychological reasons."}, 'identificationModule': {'nctId': 'NCT03801668', 'briefTitle': 'Albumin-bound Paclitaxel Plus S-1 Versus SOX as First-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'A Multi-center, Open-label, Randomized Controlled Study of Albumin-bound Paclitaxel Plus S-1 Versus Oxaliplatin Plus S-1 (SOX) as First-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma', 'orgStudyIdInfo': {'id': 'TJCC008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nab-P/S-1', 'description': 'Patients in this arm receive chemotherapy with Albumin-bound Paclitaxel plus S-1.', 'interventionNames': ['Drug: Albumin-bound Paclitaxel plus S-1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SOX', 'description': 'Patients in this arm receive chemotherapy with Oxaliplatin plus S-1.', 'interventionNames': ['Drug: Oxaliplatin plus S-1']}], 'interventions': [{'name': 'Albumin-bound Paclitaxel plus S-1', 'type': 'DRUG', 'description': 'Albumin-bound Paclitaxel 260mg/m2 IV on D1 plus S-1 80mg/m2 PO (Bid) on D1-14 every 21 days.', 'armGroupLabels': ['Nab-P/S-1']}, {'name': 'Oxaliplatin plus S-1', 'type': 'DRUG', 'description': 'Oxaliplatin 130mg/m2 IV on D1 plus S-1 80mg/m2 PO (Bid) on D1-14 every 21 days.', 'armGroupLabels': ['SOX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xianglin Yuan, MD,PHD', 'role': 'CONTACT', 'email': 'xlyuan1020@163.com', 'phone': '8627-83663406'}, {'name': 'Hong Qiu, MD,PHD', 'role': 'CONTACT', 'email': 'tjqiuhong@163.com', 'phone': '8627-83663406'}, {'name': 'Xianglin Yuan, MD,PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hong Qiu, MD,PHD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Xianglin Yuan, MD,PhD', 'role': 'CONTACT', 'email': 'xlyuan1020@163.com', 'phone': '8627-83663406'}, {'name': 'Hong Qiu, MD,PhD', 'role': 'CONTACT', 'email': 'tjqiuhong@163.com', 'phone': '8627-83663406'}], 'overallOfficials': [{'name': 'Xianglin Yuan, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Tongji Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'CSPC Ouyi Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Head of the cancer center', 'investigatorFullName': 'Xianglin Yuan', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}