Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-01-07 @ 9:57 AM
Study NCT ID:
NCT02964260
Status:
UNKNOWN
Last Update Posted:
2021-05-14
First Post:
2016-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RCT of TAE Simultaneously Combined Thermal Ablation for Large 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': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D004621', 'term': 'Embolization, Therapeutic'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006489', 'term': 'Hemostatic Techniques'}, {'id': 'D060205', 'term': 'Therapeutic Occlusion'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 410}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-13', 'studyFirstSubmitDate': '2016-11-09', 'studyFirstSubmitQcDate': '2016-11-10', 'lastUpdatePostDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '3 years', 'description': 'From complete remission of the index large tumor to patient death or the completion of this trial'}], 'secondaryOutcomes': [{'measure': 'Recurrence free survival', 'timeFrame': '3 years', 'description': 'From complete remission of the index large tumor to tumor recurrence either in- or extra- hepatic or the completion of this trial'}, {'measure': 'liver and renal function', 'timeFrame': '3 years', 'description': 'Alanine aminotransferase,Ast,total bilirubin,albumin,creatinine,Urea nitrogen'}, {'measure': 'Complications', 'timeFrame': '3 years', 'description': 'number of participants with Complications'}, {'measure': 'Times of interventional procedures', 'timeFrame': '3 years', 'description': 'The number of procedures for each patient, either TACE/TAE or ablation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HCC; Embolization; Ablation; simultaneously; sequentially'], 'conditions': ['Hepatocellular Carcinoma, Adult']}, 'descriptionModule': {'briefSummary': 'This study intends to evaluate the efficacy and safety of Transarterial embolization (TAE) simultaneously combined with thermal ablation for large hepatocellular carcinoma (HCC). Half participants will receive TAE simultaneously combined with thermal ablation and the other half receive TACE sequentially combined with thermal ablation, which is a conventional treatment for HCC patients.', 'detailedDescription': 'The treatment method "Transarterial chemoembolization (TACE) sequentially combined with thermal ablation" is recommend for large HCC patients from NCCN Guideline and Chinese guideline "Diagnosis and Treatment of Primary Liver Cancer". The details of this sequential method consist one or more times of TACE followed by thermal ablation at least one month later to make the tumor completely inactivate. The thermal ablations include multiple applicators radiofrequency or microwave ablations. However, this method includes such disadvantages. 1) The limitation of lipiodol dosage in one TACE session is 30ml so that many patients needs more sessions of TACE; (2) Lipiodol and chemical drugs is easy to leak when patients have hepatic arteriovenous fistula. (3) Repeated TACE could cause more serious side effects. (4) Tumors of many patients are still not controlled or grow too large to ablate after TACEs which increases the metastasis risk and affects the efficacy and survival time.\n\nHowever, TAE simultaneously combined with thermal ablation is another combination type which reduce the interval time between two procedures from one month to 1-3 days. TAE removes the chemical drugs and uses embolic agents such as Embosphere to obstruct vessels to enhance the effect of followed ablations. The main aim of reducing interval and remove chemical drugs is to make the tumor completely inactivate in one hospitalization like surgical operation, hoping bringing less side effects, better efficacy and longer survival time.\n\nThus the investigators will launch a prospective, multicenter randomized controlled clinical trial to compare the 3-years overall survival, safety, social and economic benefit of TAE simultaneously combined with ablation and TACE sequentially combined with ablation. The investigators expect to acquire Ia-level evidence-based medical evidence which can be accepted by the clinical guideline, popularizing, demonstrating our therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 18 to 70 years with estimated survival over 3 months\n* Number of tumors \\< 3\n* Diameter of tumor between 5cm to 15cm\n* No portal vein trunk tumoral thrombus or inferior vena cava tumoral thrombus\n* With arteriovenous fistula or arterioportal shunt fistula that can be completely embolized\n* Child-Pugh class A or B/Child score \\> 7;ECOG score \\< 2\n* Tolerable coagulation function or reversible coagulation disorders\n* Laboratory examination test: WBC≥3.0×10E9/L; Hb≥3.0×10E9/L; PLT ≥50×10E9/L; INR \\< 2.3 or PT\\< 16.5s; Cr ≤ 145.5 umul/L\n* Signed informed consent before recruiting\n\nExclusion Criteria:\n\n* Diffused HCC\n* With portal vein trunk tumoral thrombus\n* With inferior vena cava tumoral thrombus or hepatic vein tumor thrombus\n* With lymphatic metastasis or extra hepatic metastasis\n* Child-Pugh class C and can't be improved by expectant treatment\n* Untreatable coagulation disorders, severe hemogram abnormal and bleeding tendency\n* Massive intractable ascites\n* ECOG score \\> 2"}, 'identificationModule': {'nctId': 'NCT02964260', 'briefTitle': 'RCT of TAE Simultaneously Combined Thermal Ablation for Large Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Randomized Controlled Trial of Transarterial Embolization Simultaneously Combined Thermal Ablation for Large Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'TASAL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAE combined ablation simultaneously', 'description': 'TAE simultaneously combined with ablation.The treatment interval is 1-3 days between two procedures. TAE using embolic agents(Lipiodol/Gelatin sponge/PVA particles(300～500μm)/Blank microspheres).', 'interventionNames': ['Drug: Embolic agents', 'Procedure: Simultaneously', 'Device: Ablation']}, {'type': 'OTHER', 'label': 'TACE combined ablation sequentially', 'description': 'TACE sequentially combined thermal ablation.The treatment interval is 1 month between two procedures. TACE using chemotherapy drug(Doxorubicin/platinum agents) and embolic agents(Lipiodol/Gelatin sponge/PVA particles(300～500μm)/Blank microspheres).', 'interventionNames': ['Drug: Chemotherapy drug', 'Drug: Embolic agents', 'Procedure: Sequentially', 'Device: Ablation']}], 'interventions': [{'name': 'Chemotherapy drug', 'type': 'DRUG', 'otherNames': ['Chemotherapy'], 'description': 'Doxorubicin/Platinum agents', 'armGroupLabels': ['TACE combined ablation sequentially']}, {'name': 'Embolic agents', 'type': 'DRUG', 'otherNames': ['Embolization'], 'description': 'Lipiodol/Gelatin sponge/PVA/Blank microspheres', 'armGroupLabels': ['TACE combined ablation sequentially', 'TAE combined ablation simultaneously']}, {'name': 'Simultaneously', 'type': 'PROCEDURE', 'otherNames': ['Treatment interval'], 'description': '1-3 days', 'armGroupLabels': ['TAE combined ablation simultaneously']}, {'name': 'Sequentially', 'type': 'PROCEDURE', 'otherNames': ['Treatment interval'], 'description': '1 month', 'armGroupLabels': ['TACE combined ablation sequentially']}, {'name': 'Ablation', 'type': 'DEVICE', 'otherNames': ['RFA/MWA'], 'description': 'Radiofrequency ablation/Microwave ablation', 'armGroupLabels': ['TACE combined ablation sequentially', 'TAE combined ablation simultaneously']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jinhua Huang, Ph.D', 'role': 'CONTACT', 'phone': '0086-20-87343447'}, {'name': 'Jinhua Huang, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Jinhua Huang, Ph.D', 'role': 'CONTACT', 'email': 'huangjh@sysucc.org.cn', 'phone': '0086-20-87343272'}], 'overallOfficials': [{'name': 'Jinhua Huang, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Third Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Sixth Affiliated Hospital, Sun Yat-sen University', 'class': 'OTHER'}, {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Huang Jinhua', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}