Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT03950102
Status:
UNKNOWN
Last Update Posted:
2019-05-28
First Post:
2019-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SBRT as Bridging Therapy for Hepatocellular Carcinoma Patients on Transplant Waitlist
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-23', 'studyFirstSubmitDate': '2019-05-02', 'studyFirstSubmitQcDate': '2019-05-12', 'lastUpdatePostDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Risk of classical radiation induced liver disease (RILD) after SBRT', 'timeFrame': 'From time of SBRT to 3 months afterwards', 'description': "Defined as elevated liver transaminases \\>5 times of upper normal limit or worsening of Child's score by \\>2 within 3 months after SBRT"}, {'measure': 'Rate of transplant complication', 'timeFrame': 'From time of transplant to 1 months afterwards', 'description': 'Perioperative complication will be assessed according to Clavien-Dindo classification'}], 'secondaryOutcomes': [{'measure': 'Rate of dropout from transplant waitlist', 'timeFrame': 'From time of enrolment to up to 2 years', 'description': 'All HCC patients on waitlist will be assessed regularly and will be removed from waitlist if HCC stage is beyond UCSF criteria.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'referencesModule': {'references': [{'pmid': '34091914', 'type': 'DERIVED', 'citation': 'Wong TC, Lee VH, Law AL, Pang HH, Lam KO, Lau V, Cui TY, Fong AS, Lee SW, Wong EC, Dai JW, Chan AC, Cheung TT, Fung JY, Yeung RM, Luk MY, Leung TW, Lo CM. Prospective Study of Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma on Waitlist for Liver Transplant. Hepatology. 2021 Nov;74(5):2580-2594. doi: 10.1002/hep.31992. Epub 2021 Sep 30.'}]}, 'descriptionModule': {'briefSummary': 'This is a single center, prospective study to assess the efficacy and safety of using stereotactic body radiation therapy (SBRT) as bridging treatment for hepatocellular carcinoma (HCC) patients on transplant waitlist.', 'detailedDescription': 'The study population includes patients 18 years of age or older with HCC, who are accepted on waiting list for deceased donor liver transplantation (DDLT).\n\nPatient will be assessed in a multidisciplinary committee and they will receive SBRT unless otherwise contraindicated. Patients will undergo SBRT under standard protocol.\n\nPatients with HCC beyond University of California, San Francisco criteria (UCSF) will be removed from waitlist.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Radiological diagnosis of HCC confirmed according to AASLD criteria\n2. All patients who are accepted on deceased donor waiting list\n3. HCC within UCSF criteria (defined as solitary tumor \\<=6.5cm OR up to 3 tumors \\<=4.5cm, total sum \\<=8cm)\n\nExclusion Criteria:\n\n1. age \\<18 year old;\n2. Child's C cirrhosis;\n3. Eastern Cooperative Oncology Group (ECOG) score \\>2;\n4. presence of extrahepatic metastasis;\n5. radiological tumor invasion to portal, hepatic vein or its branches;\n6. absolute contraindications to RT (e.g. previous RT to liver);\n7. positive pregnancy test;\n8. unwilling or unable to adhere to study requirements and procedure;\n9. any other condition, in the investigator's judgment, that increases the risk of SBRT or prevents safe trial participation."}, 'identificationModule': {'nctId': 'NCT03950102', 'briefTitle': 'SBRT as Bridging Therapy for Hepatocellular Carcinoma Patients on Transplant Waitlist', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Prospective Study of Stereotactic Body Radiation Therapy as a Bridging Therapy for Hepatocellular Carcinoma Patients on Waiting List for Liver Transplantation', 'orgStudyIdInfo': {'id': 'UW15-191'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SBRT', 'description': 'SBRT will be used as the primary bridging therapy for HCC patients on waitlist', 'interventionNames': ['Radiation: SBRT']}], 'interventions': [{'name': 'SBRT', 'type': 'RADIATION', 'description': 'Radiation dose of 27.5-50Gy in 5 fractions over 5-14 days with a radical dose as high as achievable based on mean liver dose (MLD), while fulfilling the dose constraints of OARs', 'armGroupLabels': ['SBRT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Tiffany Wong, MBChB', 'role': 'CONTACT', 'email': 'wongtcl@hku.hk', 'phone': '22554848'}], 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Tiffany Wong, MBChB', 'role': 'CONTACT', 'email': 'wongtcl@hku.hk', 'phone': '22554848'}], 'overallOfficials': [{'name': 'Tiffany Wong, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Dr. Tiffany Cho-Lam Wong', 'investigatorAffiliation': 'The University of Hong Kong'}}}}