Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-02-26 @ 12:42 AM
Study NCT ID:
NCT01901692
Status:
COMPLETED
Last Update Posted:
2017-09-18
First Post:
2013-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sorafenib vs.TransArterial Chemoembolization Plus RadioTherapy in Hepatocellular Carcinoma With Macrovascular Invasion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}], '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': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077157', 'term': 'Sorafenib'}], 'ancestors': [{'id': 'D010671', 'term': 'Phenylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009536', 'term': 'Niacinamide'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-15', 'studyFirstSubmitDate': '2013-07-14', 'studyFirstSubmitQcDate': '2013-07-14', 'lastUpdatePostDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival (PFS) rate', 'timeFrame': 'at 12 weeks after randomization', 'description': 'Progression is defined as progressive disease (PD) by independent radiologic review according to RECIST criteria (version 1.1), termination of the assigned treatment, or death from any cause, assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons with the intention-to-treat principle.'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival (PFS) rate', 'timeFrame': 'at 24 weeks and up to 4 years after randomization', 'description': 'Progression is defined as progressive disease (PD) by independent radiologic review according to RECIST criteria (version 1.1), termination of the assigned treatment, or death from any cause, assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons.'}, {'measure': 'Radiologic response rate', 'timeFrame': 'at 12 and 24 weeks after randomization', 'description': "Radiologic response rate by independent radiologic review according to RECIST criteria (version 1.1), , assessed by Chi-square test or Fisher's exact test, as appropriate."}, {'measure': 'treatment-crossover rate', 'timeFrame': 'at 12 and 24 weeks after randomization', 'description': 'Crossover of treatment is permitted after confirming the disease progression during the initially assigned treatment, assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons.'}, {'measure': 'time to progression', 'timeFrame': 'up to 4 years after randomization', 'description': 'The median time to progression assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons.'}, {'measure': 'Overall patient survival rate', 'timeFrame': 'up to 4 years after randomization', 'description': 'The median overall patient survival rate assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons.'}, {'measure': 'Exploratory analysis for overall patient survival rate', 'timeFrame': 'up to 4 years after randomization', 'description': 'By using Cox proportional hazards model to evaluate the interaction between important baseline characteristics and the effect of treatments on overall survival.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['liver cancer', 'first-line', 'tumor thrombus', 'vascular invasion'], 'conditions': ['Hepatocellular Carcinoma']}, 'referencesModule': {'references': [{'pmid': '29543938', 'type': 'DERIVED', 'citation': 'Yoon SM, Ryoo BY, Lee SJ, Kim JH, Shin JH, An JH, Lee HC, Lim YS. Efficacy and Safety of Transarterial Chemoembolization Plus External Beam Radiotherapy vs Sorafenib in Hepatocellular Carcinoma With Macroscopic Vascular Invasion: A Randomized Clinical Trial. JAMA Oncol. 2018 May 1;4(5):661-669. doi: 10.1001/jamaoncol.2017.5847.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate and compare the efficacy and safety of sorafenib versus trans-arterial chemoembolization plus external beam radiation therapy in patients with hepatocellular carcinoma invading major intrahepatic vessels', 'detailedDescription': 'Current practice guidelines recommend only sorafenib for patients with hepatocellular carcinoma invading major intrahepatic vessels. However, recent data from observational studies suggest that the combination of transarterial chemoembolization and external beam radiotherapy would be as effective as sorafenib.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>19 years\n* Child-Pugh class A liver function\n* Performance status: Eastern Cooperative Oncology Group (ECOG) score 0 or 1\n* Hepatocellular carcinoma (HCC) confirmed by dynamic CT or MRI, or by biopsy\n* HCC invasion of first or second branch portal vein or hepatic vein or inferior vena cava\n* Reserved unilateral portal blood flow at least in partial\n* HCC size larger than 1 cm and less than 50% of total liver volume\n* No confirmed extrahepatic metastasis\n* Adequate hematopoietic function Hemoglobin ≥ 8.5 g/dL Absolute neutrophil count ≥ 750/mm3 Platelet count ≥ 30,000/mm3\n* Creatinine \\< 1.5mg/dL\n* No plan for pregnancy or breast feeding. Active contraception.\n* Willing to give informed consent\n\nExclusion Criteria:\n\n* Prior history to or exposure of transarterial chemoembolization, external beam radiation to liver, or sorafenib\n* Complete obstruction of hepatic outflow\n* Confirmed extrahepatic metastasis of HCC\n* HCC occupying more than 50% of liver volume\n* Uncontrolled ascites of hepatic encephalopathy\n* Prior liver transplantation\n* Positive for human immunodeficiency virus (HIV)\n* Active gastric or duodenal ulcer\n* Other uncontrolled comorbidities or malignancy\n* Inability to give informed consent'}, 'identificationModule': {'nctId': 'NCT01901692', 'acronym': 'START', 'briefTitle': 'Sorafenib vs.TransArterial Chemoembolization Plus RadioTherapy in Hepatocellular Carcinoma With Macrovascular Invasion', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Randomized Trial Comparing Sorafenib and Transarterial Chemoembolization Plus External Beam Radiotherapy in Patients With Hepatocellular Carcinoma Showing Macroscopic Vascular Invasion', 'orgStudyIdInfo': {'id': 'AMC IRB 2013-0627'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TACE+External beam RT', 'description': 'Transarterial chemoembolization plus external beam radiation therapy', 'interventionNames': ['Radiation: TACE+External beam RT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sorafenib', 'description': 'Sorafenib 800 mg/day orally', 'interventionNames': ['Drug: Sorafenib']}], 'interventions': [{'name': 'TACE+External beam RT', 'type': 'RADIATION', 'description': 'Trans-arterial chemoembolization (TACE) every 6 weeks + external beam radiation therapy starting within 3 weeks after first TACE', 'armGroupLabels': ['TACE+External beam RT']}, {'name': 'Sorafenib', 'type': 'DRUG', 'otherNames': ['Nexavar'], 'description': 'Sorafenib 800 mg/day orally', 'armGroupLabels': ['Sorafenib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Young-Suk Lim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Young-Suk Lim', 'investigatorAffiliation': 'Asan Medical Center'}}}}