Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-24 @ 3:31 PM
Study NCT ID:
NCT03949192
Status:
UNKNOWN
Last Update Posted:
2020-05-05
First Post:
2019-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Kangliuwan for Recurrent Grade IV Glioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-30', 'studyFirstSubmitDate': '2019-05-11', 'studyFirstSubmitQcDate': '2019-05-11', 'lastUpdatePostDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in tumor volume', 'timeFrame': '3 months', 'description': 'the volume of tumor decreased after taking Kangliuwan'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glioma of Brain', 'Recurrence']}, 'descriptionModule': {'briefSummary': 'A Prospective Exploratory Clinical Study to explore the efficacy of Hospital Traditional Chinese Medicine Preparation Kangliuwan for Recurrent Grade IV Glioma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Recurrent grade IV glioma patients and conventional treatment is invalid.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patient signed "informed consent" voluntarily;\n2. The age of patient is between 18 and 80 years;\n3. KPS score ≥40 ; The patient has normal liver and kidney function Normal heart function Better follow-up and compliance;\n\nExclusion Criteria:\n\n1. The patient did not sign "informed consent" or signed unvoluntarily.\n2. Non-glioma patients\n3. Active infection\n4. Human immunodeficiency virus (HIV) positive\n5. Hepatitis C or hepatitis B infective\n6. Pregnancy or breast-feeding women\n7. Patients did not agree to use effective contraception during treatment and the following 3 months.\n8. Patients also participated in other clinical studies.\n9. The subjects researchers believe are not suitable for participation or completion of the study.'}, 'identificationModule': {'nctId': 'NCT03949192', 'briefTitle': 'Efficacy of Kangliuwan for Recurrent Grade IV Glioma', 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'Efficacy of Hospital Traditional Chinese Medicine Preparation Kangliuwan for Recurrent Grade IV Glioma: A Prospective Exploratory Clinical Study', 'orgStudyIdInfo': {'id': 'LYS [2019] 027'}}, 'contactsLocationsModule': {'locations': [{'zip': '100054', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ge Sun, B.A.', 'role': 'CONTACT', 'email': 'sunge@163.com', 'phone': '8610-83168899'}], 'facility': 'Xuanwu Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Qingtang Lin, MD. Ph.D', 'role': 'CONTACT', 'email': 'linqingtang@xwhosp.orn', 'phone': '8610-83198362'}, {'name': 'Ge Sun, B.A.', 'role': 'CONTACT', 'email': 'sunge0923@126.com', 'phone': '8610-83198362'}], 'overallOfficials': [{'name': 'Qingtang Lin, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Xuanwu Hospital, Beijing'}, {'name': 'Xiaolan Lin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xuanwu Hospital, Beijing'}, {'name': 'Ling Chen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The General Hospital of People's Liberation Army (301 hospital)"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant director physician', 'investigatorFullName': 'Qingtang Lin', 'investigatorAffiliation': 'Xuanwu Hospital, Beijing'}}}}