Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-31 @ 1:08 PM
Study NCT ID:
NCT03192735
Status:
UNKNOWN
Last Update Posted:
2020-02-05
First Post:
2017-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Apatinib Combined With SOX Neoadjuvant Therapy for Locally Advanced Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'C104201', 'term': 'gimeracil'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2024-12-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-04', 'studyFirstSubmitDate': '2017-06-18', 'studyFirstSubmitQcDate': '2017-06-19', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radical surgical resection rate', 'timeFrame': '30 days', 'description': 'Radical surgical resection rate is defined as the rate of R0 resection'}], 'secondaryOutcomes': [{'measure': 'Pathological response rate', 'timeFrame': '30 days', 'description': 'Briefly, pathCR (Pathological complete rate) was defined as an absence of carcinoma cells in the primary site, and pathologic partial response (pathPR) was defined as less than 10% residual carcinoma cells in the specimen.'}, {'measure': 'overall response rate', 'timeFrame': '30 days', 'description': 'according to Response Evaluation Criteria in Solid Tumors RECIST Version 1.1'}, {'measure': '5-year overall survival rate', 'timeFrame': '60 months'}, {'measure': '5-year disease free survival rate', 'timeFrame': '60months'}, {'measure': 'overall postoperative morbidity rates', 'timeFrame': '30 days', 'description': 'Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.'}, {'measure': 'Duration of postoperative hospital stay', 'timeFrame': '30 days', 'description': 'Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.'}, {'measure': '30 days mortality rates', 'timeFrame': '30 days', 'description': 'Defined as the event observed within 30 days after surgery.'}, {'measure': 'adverse event', 'timeFrame': '60 months', 'description': 'An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Apatinib Combined', 'SOX', 'Neoadjuvant Therapy', 'Locally Advanced Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '34241629', 'type': 'DERIVED', 'citation': 'Lin JX, Xu YC, Lin W, Xue FQ, Ye JX, Zang WD, Cai LS, You J, Xu JH, Cai JC, Tang YH, Xie JW, Li P, Zheng CH, Huang CM. Effectiveness and Safety of Apatinib Plus Chemotherapy as Neoadjuvant Treatment for Locally Advanced Gastric Cancer: A Nonrandomized Controlled Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2116240. doi: 10.1001/jamanetworkopen.2021.16240.'}]}, 'descriptionModule': {'briefSummary': 'We star a multicentre, one-armed, clinical pilot trial intends to investigate the safety and effectiveness of Apatinib Combined With Oxaliplatin, Gimeracil and Oteracil Porassium Capsules Neoadjuvant Ttherapy for Locally Advanced Gastric Cancer(cT2-4/N+M0)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age from 18 to 75 years\n2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy\n3. cT2-4N+M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition\n4. No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.\n5. Performance status of 0 or 2 on Eastern Cooperative Oncology Group scale (ECOG)\n6. Without previous surgical, chemotherapy,radiotherapy, immunotherapy, or targeted therapy for gastric cancer.\n7. Estimate life is equal or greater than 3 months\n8. No serious heart, lung, liver dysfunction;no Jaundice and obstruction of the digestive tract; no acute infection\n9. The main organ function is normal,and meet the following criteria:\n\n * blood routine examination( No blood transfusion within 14 days)\n\n 1. HB≥100g/L，\n 2. WBC≥3.5×109/L\n 3. ANC≥1.5×109/L，\n 4. PLT≥100×109/L；\n * blood biochemical examination\n\n 1. BIL \\<1.5 Upper Limit Of Normal（ULN），\n 2. ALT and AST\\<2.5ULN，GPT≤1.5×ULT；\n 3. Cr≤1ULN，creatinine clearance\\>60ml/min（Cockcroft-Gault formula）\n10. Written informed consent\n\nExclusion Criteria:\n\n1. Pregnant and lactating women\n2. Suffering from severe mental disorder\n3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)\n4. History of previous chemotherapy or radiotherapy therapy\n5. History of other malignant disease within the past 5 years\n6. History of previous neoadjuvant chemotherapy or radiotherapy\n7. History of unstable angina or myocardial infarction within the past 6 months\n8. History of cerebrovascular accident within the past 6 months\n9. History of continuous systematic administration of corticosteroids within 1 month\n10. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer\n11. Patients with a clear tendency of gastrointestinal bleeding,such as: active ulceration,fecal occult blood test(++),The history of hematemesis and melena within 2 months,coagulation disorders(INR\\>1.5、APTT\\>1.5 ULN).\n12. Positive urinary protein(uric albumen check(++),or Twenty-four hours urinary protein content\\>1.0g)\n13. There are several factors that affect oral medicine,such as unable to swallow, uncontrollable nausea and vomitin, or chronic diarrhea and intestinal obstruction\n14. Drug allergy to experimental medicine'}, 'identificationModule': {'nctId': 'NCT03192735', 'briefTitle': 'Apatinib Combined With SOX Neoadjuvant Therapy for Locally Advanced Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fujian Medical University'}, 'officialTitle': 'Apatinib Combined With Oxaliplatin and Gimeracil and Oteracil Porassium Capsules Neoadjuvant Therapy for Locally Advanced Gastric Cance: A Multicentre, One-armed, Clinical Pilot Trial', 'orgStudyIdInfo': {'id': '2017YF004-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Apatinib Combined With SOX', 'description': 'In this group,subject will be given ApatinibMesylateTablets 500mg one time a day, from day1-day 21,per os; Oxaliplatin for Injection 130mg/m2 one time a day，ivgtt，in day1; Gimeracil and Oteracil Porassium Capsules twice times a day,from day1-day 14,per os,and the dosage according body surface area:\\<1.25m2, 40mg every time;1.25-1.5m2,50mg every time; \\>1.5m2, 60mg every time.A course of treatment need 21days. Every subject need 2-5 courses accrding to tumor assessment by clinician. The last course stop ApatinibMesylateTablets.', 'interventionNames': ['Drug: ApatinibMesylateTablets']}], 'interventions': [{'name': 'ApatinibMesylateTablets', 'type': 'DRUG', 'otherNames': ['Oxaliplatin for Injection', 'Gimeracil and Oteracil Porassium Capsules'], 'description': 'Subject will be given ApatinibMesylateTablets 500mg/per day, from day1-day 21,per os; Oxaliplatin for Injection 130mg/m2 /per day，ivgtt，in day1; Gimeracil and Oteracil Porassium Capsules twice times a day,from day1-day 14,per os,and the dosage according body surface area:\\<1.25m2, 40mg every time;1.25-1.5m2,50mg every time; \\>1.5m2, 60mg every time.A course of treatment need 21days. Every subject need 2-5 courses accrding to tumor assessment by clinician. The last course stop ApatinibMesylateTablets.', 'armGroupLabels': ['Apatinib Combined With SOX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350000', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Fujian Medical University Union Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang-Ming Huang, Prof.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Chang-Ming Huang, Prof.', 'investigatorAffiliation': 'Fujian Medical University'}}}}