Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-03-01 @ 10:10 AM
Study NCT ID:
NCT02821533
Status:
TERMINATED
Last Update Posted:
2017-08-22
First Post:
2016-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chemoembolization for Hepatocellular Carcinoma
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000970', 'term': 'Antineoplastic Agents'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'whyStopped': 'Poor case accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-18', 'studyFirstSubmitDate': '2016-06-07', 'studyFirstSubmitQcDate': '2016-06-29', 'lastUpdatePostDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor response', 'timeFrame': '3 months after treatment', 'description': 'CT scan abdomen will be performed 3 months after the first treatment. Tumor response by CT was classified into complete response (CR), partial response (PR), static disease (SD, and progressive disease (PD) according to European Association for the Study of the Liver (EASL) necrosis guidelines,'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '30 days after treatment', 'description': 'No further treatment was given when there was deterioration in liver function or performance status meeting the exclusion criteria'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'The aim of the current study is to study the safety and effectiveness of TACE using a high dose of cisplatin for treatment of HCC. It is hypothesized that the formulation is safe and it improves the therapeutic effect of conventional TACE.', 'detailedDescription': 'Most patients with HCC are diagnosed at an intermediate and advanced stage when the tumors become unresectable, transcatheter arterial chemoembolisation (TACE) has been widely accepted as a standard treatment for them in most international management protocols. The therapeutic effect of TACE in terms of objective tumor response is variable and modest (27%-40%), indicating that there is actually much room for improvement in the treatment. Internationally, high doses and combination of chemotherapeutic agents are being routinely and widely used for TACE in major medical centers. Locally, a low dose of cisplatin (10mg) has been used as the chemotherapeutic agent for TACE in Hong Kong. There is evidence showing that the component of chemotherapeutic agent in TACE does play a significant role in the treatment effect of TACE. In an attempt to improve the treatment effect of TACE, the investigators propose a formulation of TACE using a high dose of cisplatin as chemotherapeutic agent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatient factor\n\n1. Age \\> 18\n2. Child-Pugh A or B cirrhosis\n3. ECOG performance status Grade 2 or below\n4. No serious concurrent medical illness\n5. No prior treatment for HCC except for liver resection\n6. Creatinine clearance \\>55ml/min.\n\nTumor factor\n\n1. HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology.\n2. Unresectable and locally advanced disease without extra-hepatic disease\n3. Massive expansive tumor type with measurable lesion on CT\n4. Total tumor mass \\< 50% liver volume\n5. Largest tumor of greatest dimension ≤ 15cm\n\nExclusion Criteria:\n\nPatient factor\n\n1. Serum creatinine level \\> 130 umol/L\n2. Presence of biliary obstruction not amenable to percutaneous drainage\n3. Child-Pugh C cirrhosis\n\nEvidence of impaired liver function\n\n1. History of hepatic encephalopathy, or\n2. Intractable ascites not controllable by medical therapy, or\n3. History of variceal bleeding within last 3 months, or\n4. Serum total bilirubin level \\> 40 umol/L, or\n5. Serum albumin level \\< 30g/L, or\n6. INR \\> 1.3\n\nTumor factor\n\n1. Presence of extrahepatic metastasis\n2. Infiltrative lesion\n3. Diffuse lesion\n\nVascular complications\n\n1. Hepatic artery thrombosis, or\n2. Partial or complete thrombosis of the main portal vein, or\n3. Tumor invasion of portal branch of contralateral lobe, or\n4. Hepatic vein tumor thrombus, or\n5. Significant arterioportal shunt, or\n6. Significant arteriovenous shunt'}, 'identificationModule': {'nctId': 'NCT02821533', 'briefTitle': 'Chemoembolization for Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Chemoembolization for Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'VIR-13-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'TACE using a high dose of cisplatin', 'description': 'Two consecutive treatments at two months apart will be given. A delay in the second treatment is allowed if patients do not recover to an acceptable state for subsequent cycle of treatment. Two treatment sessions at one month apart may be required for each complete treatment to cover all lesions when the lesions are diffusely distributed and involving both lobes.', 'interventionNames': ['Procedure: TACE', 'Drug: Cisplatin']}], 'interventions': [{'name': 'TACE', 'type': 'PROCEDURE', 'description': 'TACE is performed under local anesthesia with right femoral puncture. The feeding lobar hepatic artery is selectively catheterized for drug delivery.', 'armGroupLabels': ['TACE using a high dose of cisplatin']}, {'name': 'Cisplatin', 'type': 'DRUG', 'otherNames': ['chemotherapeutic agent'], 'description': 'Cisplatin will be mixed with a mixture of Lipiodol and ethanol (LEM), which consists of 33% ethanol by volume in Lipiodol, in a ratio of 2mg cisplatin per mL of LEM, and delivered through catheters or microcatheters to the tumors until there is flow reduction at the tumor feeders. The total dose of cisplatin given in each treatment session is limited to 100mg (50mL LEM) in each treatment session. The usual volume of LEM delivered will be 20 - 30 mL.', 'armGroupLabels': ['TACE using a high dose of cisplatin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Simon Yu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DIIR, CUHK, Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Simon Yu', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}