Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-01-11 @ 2:30 AM
Study NCT ID:
NCT03129256
Status:
COMPLETED
Last Update Posted:
2019-12-10
First Post:
2017-04-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Exploration of Apatinib Combined With S-1 in Patients With Advanced Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract 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': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-09', 'studyFirstSubmitDate': '2017-04-17', 'studyFirstSubmitQcDate': '2017-04-21', 'lastUpdatePostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival(PFS)', 'timeFrame': '2 years', 'description': 'PFS is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival(OS)', 'timeFrame': '2 years', 'description': 'Overall Survival is defined as the length of time from random assignment to death or to last contact.'}, {'measure': 'Objective response rate(ORR)', 'timeFrame': '2 years', 'description': 'Objective response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response according to Response Evaluation Criteria in Solid Tumors 1.1（RECIST1.1）'}, {'measure': 'Disease Control Rate(DCR)', 'timeFrame': '2 years', 'description': 'Disease Control Rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease according to radiological assessments.'}, {'measure': 'Adverse Events(AEs)', 'timeFrame': '2 years', 'description': 'AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['non-small cell lung cancer', 'Apatinib', 'S1'], 'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This study is to explore the potential efficacy and safety of low-dose Apatinib combined with S-1 in patients with advanced lung cancer. Patients with advanced NSCLC will be treated with oral apatinib and S-1 after treatment failure of standard regimen.', 'detailedDescription': 'Apatinib is a tyrosine kinase inhibitor which selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR-2). The anti-angiogenesis effect of apatinib has been proved in preclinical tests. Phase II study has showed an improvement of progression free survival in pretreated patients. S-1, an oral fluoropyrimidine has considerable effectiveness with mild side effect in patients failed to standard treatments. The purpose of this study is to evaluate the potential efficacy and safety of low-dose Apatinib combined with S-1 in heavily pretreated patients with advanced lung cancer. And to explore the biomarkers of antiangiogenesis therapy and the possible mechanisms of treatment resistance on the basis of next generation sequencing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed Non-small cell lung cancer\n* Patients with extracranial measurable lesions\n* Patients with NSCLC failed for standard treatments\n* Eastern Cooperative Oncology Group performance status score: 0\\~2 and life expectancy of more than 3 months\n* Major organs functioning properly\n* Compliance is good and agreed to cooperate with the survival of follow-up\n* Informed consent\n\nExclusion Criteria:\n\n* Contraindications for investigational agents\n* Patients with clinical symptoms of brain metastases or meningeal metastasis\n* Tumor invade big vessels or close to big vessels\n* Uncontrolled hypertension\n* Abnormal coagulation (INR\\>1.5 or Prothrombin Time\\>ULN+4, or Activated Partial Thromboplastin Time\\>1.5 ULN), bleeding tendency or receiving coagulation therapy\n* Hemoptysis, more than 2.5ml daily\n* Thrombosis in 12 months, including pulmonary thrombosis, stoke, or deep venous thrombosis.\n* Myocardial ischemia or infarction more than stage II, cardiac insufficiency.\n* Received big surgery, had bone fracture or ulcer in 4 weeks.\n* Urine protein≥++, or urine protein in 24 hours≥1.0g'}, 'identificationModule': {'nctId': 'NCT03129256', 'acronym': 'EASE', 'briefTitle': 'An Exploration of Apatinib Combined With S-1 in Patients With Advanced Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Changzhou Cancer Hospital of Soochow University'}, 'officialTitle': 'An Exploratory Study of Low-dose Apatinib Combined With S-1 in Patients With Advanced Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'CCH001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Apatinib & S-1', 'description': 'Apatinib Mesylate tablet combined with S-1 Capsules Apatinib Mesylate tablet 250mg once daily combined with S-1(Tegafur,Gimeracil and Oteracil Potassium Capsules) 40mg\\~60mg twice daily by mouth, d1-14, repeated every 3 weeks.', 'interventionNames': ['Drug: Apatinib Mesylate tablet combined with S-1 capsules']}], 'interventions': [{'name': 'Apatinib Mesylate tablet combined with S-1 capsules', 'type': 'DRUG', 'otherNames': ['Ai Tan combined with S-1', 'Apatinib combined with S-1'], 'description': 'Oral use with low-dose Apatinib combined with S-1 until disease progression', 'armGroupLabels': ['Apatinib & S-1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '213000', 'city': 'Changzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Changzhou Cancer Hospital of Soochow University', 'geoPoint': {'lat': 31.77359, 'lon': 119.95401}}], 'overallOfficials': [{'name': 'Tong Zhou, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changzhou Cancer Hospital of Soochow University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changzhou Cancer Hospital of Soochow University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}