Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2026-01-25 @ 3:52 PM
Study NCT ID:
NCT02229058
Status:
COMPLETED
Last Update Posted:
2017-07-27
First Post:
2014-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Albumin Bound Paclitaxel Plus S-1 as the First Line Chemotherapy in Advanced or Recurrent 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': 'D000068196', 'term': 'Albumin-Bound Paclitaxel'}, {'id': 'C079198', 'term': 'S 1 (combination)'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-25', 'studyFirstSubmitDate': '2014-03-08', 'studyFirstSubmitQcDate': '2014-08-27', 'lastUpdatePostDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Progression-free survival is determined from the date of treatment to PD or death.'}], 'secondaryOutcomes': [{'measure': 'Response rate', 'timeFrame': 'up to one year', 'description': 'the ratio of patients whose efficiency evaluation is CR or PR'}, {'measure': 'Overall survival', 'timeFrame': 'OS follow-up period: 18 months or 80% OS events, whichever occurs first.', 'description': 'the date of treatment to death from any cause or the last follow-up date'}, {'measure': 'Disease control rate', 'timeFrame': 'AEs (Adverse events) should be recorded during the study period and six months after last IMP administration', 'description': 'the ratio of patients whose efficiency evaluation is CR or PR or SD'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gastric Cancer', 'Albumin Bound Paclitaxel', 'S-1', 'First Line'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness and safety of s-1 plus Albumin Bound Paclitaxel as first-line therapy in the treatment of patients with advanced gastric cancer.', 'detailedDescription': 'As the first phase II clinical trial of fluoropyrimidines plus Nab-PTX in AGC patientsphase II trial, this study aimed to evaluate the efficacy and safety of S-1 plus Nab-PTX as a first-line treatment for patients with metastatic gastric cancer. All patients were orally treated with S-1 in doses of 40 mg (BSA\\<1.25 m2), 50 mg (1.25≤BSA\\<1.50 m2) and 60 mg (BSA≥1.50 m2) b.i.d. on days 1-14 in combination with Nab-PTX (240 mg/m2, divided on days 1 and 8, intravenously for 30 minutes) of each 21-day cycle. Treatment was planned for 6 cycles or until progression, unacceptable toxicity, or patient refusal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the stomach with inoperable locally advanced or recurrent and/or metastatic disease.\n* Male or female.\n* Age ≥ 18.\n* No previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study).\n* Measurable disease, according to the Response Evaluation Criteria in Solid Tumours(RECIST)\n* ECOG Performance status 0, 1 or 2\n* Haematological, Biochemical and Organ Function: Neutrophil count \\>2.0 × 10 9/L, platelet count \\> 100 ×10 9/L. Serum bilirubin\\< 1.5 × upper limit of normal (ULN); or, AST or ALT \\< 2.5 × ULN (or \\< 5 × ULN in patients with liver metastases); or, alkaline phosphatase\\< 2.5 × ULN (or \\> 5 × ULN in patients with liver metastases,Creatinine clearance \\> 60 mL/min.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Prior palliative chemotherapy.\n* Received any investigational drug treatment within 30 days of start of study treatment.\n* Patients with active gastrointestinal bleeding.\n* Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma.\n* History or clinical evidence of brain metastases.\n* Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes.\n* Pregnancy women.\n* Subjects with reproductive potential not willing to use an effective method of contraception.\n* Patients with known active infection with HIV.\n* Known hypersensitivity to any of the study drugs.\n* Neurological toxicity ≥ grade 2 NCI-CTCAE.'}, 'identificationModule': {'nctId': 'NCT02229058', 'briefTitle': 'Albumin Bound Paclitaxel Plus S-1 as the First Line Chemotherapy in Advanced or Recurrent Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Phase II Study of Albumin Bound Paclitaxel Plus S-1 as the First Line Chemotherapy in Advanced or Recurrent Gastric Cancer', 'orgStudyIdInfo': {'id': 'ABI-SG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Albumin Bound Paclitaxel plus S-1', 'description': 'Abraxane 120 mg/m2, D1,D8;S-1 40\\~60mg QD D1-D14,every 3 weeks until disease progress or intolerable toxicity.', 'interventionNames': ['Drug: Albumin Bound Paclitaxel', 'Drug: S-1']}], 'interventions': [{'name': 'Albumin Bound Paclitaxel', 'type': 'DRUG', 'otherNames': ['abraxane'], 'description': '120 mg/m2, D1,D8,every 3 weeks until disease progress or intolerable toxicity.', 'armGroupLabels': ['Albumin Bound Paclitaxel plus S-1']}, {'name': 'S-1', 'type': 'DRUG', 'description': '40mg QD D1-D14,every 3 weeks,for BSA\\<1.25 m2, 50mg QD D1-D14,every 3 weeks,for BSA=1.25～1.5m2, 60mg QD D1-D14,every 3 weeks,for BSA\\>1.5m2,until disease progress or intolerable toxicity.', 'armGroupLabels': ['Albumin Bound Paclitaxel plus S-1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Ruihua Xu, M.D,Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medical Oncology,Vice-president of Sun Yat-sen University Cancer Center', 'investigatorFullName': 'Ruihua Xu', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}