Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-03-01 @ 6:28 AM
Study NCT ID:
NCT00843934
Status:
UNKNOWN
Last Update Posted:
2012-10-19
First Post:
2009-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Transcatheter Arterial 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': 'D015251', 'term': 'Epirubicin'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-10-17', 'studyFirstSubmitDate': '2009-02-12', 'studyFirstSubmitQcDate': '2009-02-12', 'lastUpdatePostDateStruct': {'date': '2012-10-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'response rate', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Carcinoma, Hepatocellular', 'Trans arterial chemoembolization', 'Epirubicin', 'Cisplatin'], 'conditions': ['Carcinoma, Hepatocellular']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy and safety of cisplatin (CDDP) and epirubicin (EPI) in the treatment of transcatheter chemoembolization for Hepatocellular Carcinoma (HCC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must be histologically or clinically proven HCC, inoperable, no indication of local treatment and has measurable lesions.\n* Subject must to be the first experience of TACE.\n* Subject has no extra-hepatic tumor and no obstruction of main portal vein.\n* Subjects must have fully recovered from previous treatment (at least 4 weeks interval is needed from prior chmotherapy or radiation therapy).\n* ECOG performance status 0-2\n* Child-pugh Class A or B\n* Subject must have adequate functions of bonemarrow, renal, circulatory organs and appropriate examination results as below:\n\n 1. Serum Total Bilirubin 2.0mg/mL\n 2. WBC 3000/mm3\n 3. PLT 50000/mm3\n 4. Hb 9.0g/dL\n 5. Creatinine ; upper normal limit (UNL)\n 6. BUN 25mg/dL\n* Written informed consent\n\nExclusion Criteria:\n\n* Subject has extra hepatic metastasis.\n* Tumor thrombosis exists at main portal vein.\n* Remarkable artery-portal vein shunt or veno-arterial shunt.\n* Uncontrollable ascites or pleural effusion.\n* History of severe hypersensitivity.\n* Any previous TACE or TAE for HCC.\n* Any previous chemotherapy using epirubicin or CDDP.\n* Complications as below (except chronic hepatitis or liver cirrhosis)\n\n 1. Severe heart disease\n 2. Myocardial infarction within 6 months\n 3. Renal insufficiency\n 4. Active infections (except virous hepatitis)\n 5. Gastrointestinal bleeding\n 6. Active double cancer\n 7. Hepatic encephalopathy or heavy mental disorder.\n* Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant.\n* Any subject judged by the investigator to be unfit for any reason to participate in the study.'}, 'identificationModule': {'nctId': 'NCT00843934', 'acronym': 'ACE500', 'briefTitle': 'Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Nihon University'}, 'officialTitle': 'Randomized Controlled Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'ACE500'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'anti-cancer agent', 'interventionNames': ['Drug: epirubicin', 'Drug: Cisplatin']}], 'interventions': [{'name': 'epirubicin', 'type': 'DRUG', 'otherNames': ['epi-adriamycin'], 'description': 'Arm E: Suspension is prepared before arterial infusion as follows: Epirubicin is dissolved with water-soluble, non-ionized contrast medium then mixed with Lipiodol by pumping. Then this suspension is administered by catheter as quick as possible, and gelatin is infused for arterial embolization. Maximum dose of EPI and Lipiodol are 60mg/m2 and 0.3mL/Kg, respectively.', 'armGroupLabels': ['anti-cancer agent']}, {'name': 'Cisplatin', 'type': 'DRUG', 'otherNames': ['CDDP'], 'description': 'Arm C: Suspension is prepared before arterial infusion as follows: Cisplatin (Water soluble CDDP: IA CALL) is mixed with Lipiodol. Then this suspension is administered by catheter as quick as possible, and gelatin is infused for arterial embolization. Maximum dose of Cisplatin and Lipiodol are 65mg/m2 and 0.3mL/Kg, respectively.', 'armGroupLabels': ['anti-cancer agent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '173-8610', 'city': 'tabashi City', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Masashi Fujii, MD', 'role': 'CONTACT', 'email': 'masashi.fujii@gioncology.jp', 'phone': '+81332931711', 'phoneExt': '207'}, {'name': 'Tadatoshi Takayama, MD', 'role': 'CONTACT', 'email': 'Takayama.Tadatoshi@nihon-u.ac.jp', 'phone': '+81339728111', 'phoneExt': '2471'}], 'facility': 'Department of Digestive Surgery, Nihon University School of Medicine', 'geoPoint': {'lat': 35.74893, 'lon': 139.71497}}], 'centralContacts': [{'name': 'Masashi Fujii, MD', 'role': 'CONTACT', 'email': 'masashi.fujii@gioncology.jp', 'phone': '+81332981711'}, {'name': 'Tadatoshi Takayama, MD', 'role': 'CONTACT', 'email': 'Takayama.Tadatoshi@nihon-u.ac.jp', 'phone': '+81339728111'}], 'overallOfficials': [{'name': 'Tadatoshi Takayama, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Digestive Surgery Nihon University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nihon University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Masashi Fujii', 'investigatorAffiliation': 'Nihon University'}}}}