Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-04-16 @ 2:54 PM
Study NCT ID:
NCT01966133
Status:
UNKNOWN
Last Update Posted:
2017-01-09
First Post:
2013-10-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TACE as an Adjuvant Therapy After Hepatectomy for 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004998', 'term': 'Ethiodized Oil'}, {'id': 'D004317', 'term': 'Doxorubicin'}], 'ancestors': [{'id': 'D007459', 'term': 'Iodized Oil'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 280}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-06', 'studyFirstSubmitDate': '2013-10-16', 'studyFirstSubmitQcDate': '2013-10-16', 'lastUpdatePostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Health-related quality of life assessment', 'timeFrame': '1-year after surgery', 'description': 'The quality of life assessment was measured by Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire (Chinese version 3)'}], 'primaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': '3 years after operation'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '3-year after surgery'}, {'measure': 'Complications of transarterial chemoembolisation', 'timeFrame': '3-month after transarterial chemoembolisation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HCC', 'Randomised controlled trial', 'TACE', 'Resection'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'Investigators hypothesise that the use of transarterial chemoembolisation (TACE) after liver resection in patients with hepatocellular carcinoma can eradicate residual cancer cells in the liver and thus improve survival of patients with high risk factors for residual tumor. The aim of this study is to compare the survival of patients with high risk factors for residual tumor undergoing liver resection plus post-operative TACE versus liver resection alone.', 'detailedDescription': 'Liver resection is the mainstay of curative treatment for hepatocellular carcinoma (HCC). However, recurrence is common after surgery and most occurs in the liver, especially for the patients with high risk factors for residual tumor, such as tumors with a diameter more than 5 cm, multiple nodules, and microvascular invasion. Transarterial chemoembolisation (TACE) is an effective palliative treatment for HCC. It involves the infusion of chemotherapeutic agent admixed with iodised oil followed by embolisation of the hepatic arterial flow using small particles. This procedures allows application of smaller dose of chemotherapy concentrated to the liver and thus is well tolerated with minimal side effects. The main complications of TACE are liver function damage, mild feverish symptoms, vomit , etc. But most of them are reversible.\n\nWe conduct a randomised controlled trial evaluating the efficacy of using TACE after hepatectomy in HCC patients with high risk factors for residual tumor (tumors with a diameter more than 5 cm, multiple nodules, or microvascular invasion).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HCC patients received curative hepatectomy with negative resection margin\n* Tumors with a diameter more than 5 cm, multiple nodules, or microvascular invasion were defined as high risk factors for residual tumor and used for patient stratification.\n* Age from 18 to 70\n* Child-Pugh class A\n* ASA class I to III\n* ECOG performance status Grade 0 or 1\n\nExclusion Criteria:\n\n* Patients receiving concomitant local ablation or previous TACE\n* Main portal vein tumour thrombus extraction during hepatectomy\n* Tumour arising from caudate lobe\n* Presence of extra-hepatic disease\n* Impaired liver function with either clinically detected ascites, hepatic encephalopathy, serum albumin \\< 25g/L or bilirubin \\> 50micromol/L\n* Renal impairment with creatinine \\> 200micromol/L\n* Severe concurrent medical illness persisting \\> 6 weeks after hepatectomy\n* History of other cancer\n* Hepatic artery anomaly making TACE not possible\n* Allergy to doxorubicin or lipiodol\n* Pregnant woman\n* Informed consent not available'}, 'identificationModule': {'nctId': 'NCT01966133', 'briefTitle': 'TACE as an Adjuvant Therapy After Hepatectomy for HCC', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Randomised Controlled Trial on Adjuvant Transarterial Chemoembolisation After Curative Hepatectomy for Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'LCI-125-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'no interventions were assigned'}, {'type': 'ACTIVE_COMPARATOR', 'label': "TACE('Ethiodized Oil + Doxorubicin)", 'description': 'TACE using Ethiodized Oil + Doxorubicin mixture was infused through catheter placed at hepatic artery followed by gelfoam embolisation. This is performed 4-6 weeks after surgery.', 'interventionNames': ['Drug: Ethiodized Oil + Doxorubicin']}], 'interventions': [{'name': 'Ethiodized Oil + Doxorubicin', 'type': 'DRUG', 'otherNames': ['doxorubicin-lipiodol mixture'], 'description': 'TACE using doxorubicin-lipiodol mixture', 'armGroupLabels': ["TACE('Ethiodized Oil + Doxorubicin)"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Jia Fan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Liver cancer institute, Fudan university'}, {'name': 'Jian Zhou, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Liver Cancer Institute, Zhong Shan Hospital, Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jia Fan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'President of zhongshan hospital, Fudan University', 'investigatorFullName': 'Jia Fan', 'investigatorAffiliation': 'Fudan University'}}}}