Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT07278102
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-11
First Post:
2025-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Observational Study on Efficacy of TARE for Early Stage HCC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-29', 'studyFirstSubmitDate': '2025-11-29', 'studyFirstSubmitQcDate': '2025-11-29', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'From enrollment to the end of treatment at 3 years', 'description': 'Overall survival'}, {'measure': 'best target lesion response', 'timeFrame': '"From enrollment to the end of treatment at 3 years', 'description': 'best target lesion response'}], 'secondaryOutcomes': [{'measure': 'Time to target lesion progression', 'timeFrame': 'From enrollment to the end of treatment at 3 years', 'description': 'Time to target lesion progression'}, {'measure': 'Time to overall progression', 'timeFrame': 'From enrollment to the end of treatment at 3 years', 'description': 'Time to overall progression'}, {'measure': 'Treatment-related adverse events rates', 'timeFrame': 'From enrollment to the end of treatment at 3 years', 'description': 'Treatment-related adverse events rates'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Radioembolization', 'Hepatocellular Carcinoma (HCC)', 'Early Stage']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.tarekorea.com/company/02/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The aim of the current study is to analyze treatment outcomes (best target lesion response, overall survival, time to target lesion progression, time to overall progression, and treatment-related adverse event) using prospectively collected clinical and imaging data in patients with BCLC 0 or A HCCs treated with TheraSphere® in four large-volume hospitals from Korea. The results will pave the way for expanding 90Y-TARE indication and refining reimbursement guidelines, and provide baseline data for possible subsequent future studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving TARE using TheraSphere® Treatment naïve BCLC 0 or A single HCC up to 8 cm (diagnosed according to diagnostic criteria of KLCA-NCC) Tumor involvement \\< 50% of total liver volume based on dynamic CT or MRI Age \\> or = 18 ECOG performance status 0 AST/ALT \\< or = 5 times the upper limits of normal A life expectancy \\> 3 months Non-pregnant with an acceptable contraception in premenopausal women Ability to provide written informed consent and to comply with all study conditions', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A. Patients receiving TARE using TheraSphere® B. Treatment naïve BCLC 0 or A single HCC up to 8 cm (diagnosed according to diagnostic criteria of KLCA-NCC) C. Tumor involvement \\< 50% of total liver volume based on dynamic CT or MRI D. Age \\> or = 18 E. ECOG performance status 0 F. AST/ALT \\< or = 5 times the upper limits of normal G. A life expectancy \\> 3 months H. Non-pregnant with an acceptable contraception in premenopausal women I. Ability to provide written informed consent and to comply with all study conditions\n\nExclusion Criteria:\n\n* A. Contraindications to angiography and selective catheterization B. Known anaphylaxis to iodinated contrast C. Expected lung dose \\> 30Gy per a session D. Unable to avoid non-target 90Y flow into the extrahepatic organs except the lungs E. Decompensated liver cirrhosis (Child-Pugh score \\> 7) F. Active uncontrolled infection G. Pregnancy H. Current or history (\\< or = 5 years) of malignancies in the other organs I. History of liver transplantation J. Any vascular invasion'}, 'identificationModule': {'nctId': 'NCT07278102', 'acronym': 'KURE-YTT-HCC', 'briefTitle': 'A Prospective Observational Study on Efficacy of TARE for Early Stage HCC', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Korean Multicenter Prospective Observational Study on Efficacy of 90Y for Hepatocellular Carcinoma-early Stage', 'orgStudyIdInfo': {'id': 'KURE-YTT-HCC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TARE', 'description': 'early stage hepatocellular carcinoma', 'interventionNames': ['Procedure: transarterial radioembolization']}], 'interventions': [{'name': 'transarterial radioembolization', 'type': 'PROCEDURE', 'description': 'TARE with 90Y', 'armGroupLabels': ['TARE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Center, Korea', 'class': 'OTHER_GOV'}, {'name': 'Severance Hospital', 'class': 'OTHER'}, {'name': 'Samsung Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yoon Jun Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}