Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-01-04 @ 1:12 PM
Study NCT ID:
NCT03333967
Status:
UNKNOWN
Last Update Posted:
2017-11-07
First Post:
2017-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Real World Study of Apatinib for Gastric Cancer Treatment in Anhui Province
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-06', 'studyFirstSubmitDate': '2017-10-01', 'studyFirstSubmitQcDate': '2017-11-06', 'lastUpdatePostDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of life score', 'timeFrame': '1year', 'description': 'Quality of life score is a questionnaire developed to assess the quality of life of cancer patients.'}, {'measure': 'adverse events', 'timeFrame': '1year', 'description': 'adverse events are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.'}], 'primaryOutcomes': [{'measure': 'Progress free survival', 'timeFrame': '1 year', 'description': 'Progress free survival 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': 'disease control rate', 'timeFrame': '1year', 'description': 'Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1'}, {'measure': 'Objective tumor response rate', 'timeFrame': '1year', 'description': 'Objective tumor response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments'}, {'measure': 'overall survival', 'timeFrame': '3year', 'description': 'overall survival is defined as the length of time from random assignment to death or to last contact.'}, {'measure': 'Disease-free survival', 'timeFrame': '1 year', 'description': 'Disease-free survival is defined as the length of time from the date of randomization to the date of first documentation of relapse of gastric cancer or any other type of cancer or death.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['apatinib'], 'conditions': ['Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '32821164', 'type': 'DERIVED', 'citation': 'Peng W, Zhang F, Wang Z, Li D, He Y, Ning Z, Sheng L, Wang J, Xia X, Yu C, Wang Z, Zhao Y, Liang H, Hu B, Sun C, Wang D, Cheng Y, Pan M, Xia L, Guo X, Zhang Y, Hu Z, Li X, Lu L, Zhang J, Qian H, Xie H, Sun G. Large Scale, Multicenter, Prospective Study of Apatinib in Advanced Gastric Cancer: A Real-World Study from China. Cancer Manag Res. 2020 Aug 6;12:6977-6985. doi: 10.2147/CMAR.S249153. eCollection 2020.'}, {'pmid': '32441892', 'type': 'DERIVED', 'citation': 'Du Y, Cao Q, Jiang C, Liang H, Ning Z, Ji C, Wang J, Zhou C, Jiang Z, Yu C, Li L, Zhao Y, Xu Y, Xu T, Hu W, Wang D, Cheng H, Wang G, Zhou J, Wang S, Zhang Y, Hu Z, Li X, Lu D, Zhang J, Xie H, Sun G. Effectiveness and safety of low-dose apatinib in advanced gastric cancer: A real-world study. Cancer Med. 2020 Jul;9(14):5008-5014. doi: 10.1002/cam4.3105. Epub 2020 May 22.'}]}, 'descriptionModule': {'briefSummary': 'The investigators conduct the real world study to explore the efficacy and safety of Apatinib in gastric cancer .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients of gastric cancer in Anhui province', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female patients .\n2. Confirmed by Pathology or histology of Gastric cancer\n3. Patients should be voluntary to the trial and provide with signed informed consent\n4. The researchers believe patients can benefit from the study.\n\nExclusion Criteria:\n\n1. Patients with a known history of allergic reactions and/or hypersensitivity attributed to apatinib or its accessories\n2. Pregnant or lactating women\n3. Patients with Apatinib contraindications\n4. Patients of doctors considered unsuitable for the trial'}, 'identificationModule': {'nctId': 'NCT03333967', 'briefTitle': 'The Real World Study of Apatinib for Gastric Cancer Treatment in Anhui Province', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Anhui Medical University'}, 'officialTitle': 'The Real World Study of Apatinib for Gastric Cancer Treatment in Anhui Province', 'orgStudyIdInfo': {'id': 'AHAT-104'}}, 'contactsLocationsModule': {'locations': [{'zip': '230000', 'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guoping Sun, doctor', 'role': 'CONTACT', 'email': 'gps_anmu@126.com', 'phone': '0551-62922249'}], 'facility': 'First Affiliated Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}], 'centralContacts': [{'name': 'guoping sun, doctor', 'role': 'CONTACT', 'email': 'gpsun_ahmu@126.com', 'phone': '0551-62922249'}], 'overallOfficials': [{'name': 'China Anhui', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Affiliated Hospital of Anhui Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Anhui Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}