Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
Study NCT ID:
NCT03533920
Status:
COMPLETED
Last Update Posted:
2018-10-01
First Post:
2018-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-09-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-27', 'studyFirstSubmitDate': '2018-05-11', 'studyFirstSubmitQcDate': '2018-05-11', 'lastUpdatePostDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate by independent evaluator', 'timeFrame': '4 weeks after treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma Non-resectable']}, 'descriptionModule': {'briefSummary': 'Pivotal Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 19 years\n* Diagnosis of HCC\n* Unresectable asymtomatic uninodular or multinodular tumor.\n* Subject who maintain clinically normal hepatopetal flow without main portal vein closure\n* At least one measurable target lesion by CT or MRI which 10 mm or more and 100 mm or less.\n* ECOG Performance Status of 0 or 1.\n* Child-Pugh class A or B\n* Life expectancy of at least 6 months.\n\nExclusion Criteria:\n\n* Another primary tumour, with the exception of conventional basal cell carcinoma or superficial bladder neoplasia\n* Hepatic resection, liver transplantation or Percutaneous local treatment\n* Previously received HCC related medical procedure\n* Previously treated with anthracyclines\n* Only measurable disease is within an area of the liver previously subjected to radiotherapy.\n* Child Pugh C\n* Active gastrointestinal bleeding within 6 months from screening.\n* Total bilirubin \\> 3mg/dL\n* WBC \\< 3,000cells/mm3\n* Platelet \\< 50,000mm3\n* Serum creatinine \\> 2mg/dL\n* INR\\> 1.4\n* ALT and AST \\> 5 times UNL\n* Diffuse HCC defined as \\>50% tumour involvement of the whole liver.'}, 'identificationModule': {'nctId': 'NCT03533920', 'briefTitle': 'Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jeil Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Single-arm, Multicenter, Open, Pivotal Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'UNI-DEB-Pivotal'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UNI-DEB', 'interventionNames': ['Device: UNI-DEB']}], 'interventions': [{'name': 'UNI-DEB', 'type': 'DEVICE', 'description': 'Applicate the TACE with UNI-DEB to unresectable hepatocellular carcinoma patient', 'armGroupLabels': ['UNI-DEB']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Uijeongbu ST. Mary's Hospital", 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Incheon', 'country': 'South Korea', 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Pusan', 'country': 'South Korea', 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Seoul ST. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jeil Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}