Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT03591705
Status:
UNKNOWN
Last Update Posted:
2021-09-22
First Post:
2018-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TACE-HAIC vs. HAIC for Potentially Resectable 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-20', 'studyFirstSubmitDate': '2018-07-09', 'studyFirstSubmitQcDate': '2018-07-09', 'lastUpdatePostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression-free survival', 'timeFrame': '6-12 months', 'description': 'Time to progression, last follow-up or death after random assignment to TACE-HAIC or HAIC'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '6-12 months', 'description': 'time to death or last follow-up after random assignment to TACE-HAIC or HAIC'}, {'measure': 'Downstage hepatectomy rate', 'timeFrame': '6-12 months', 'description': 'The hepatectomy rate after TACE-HAIC or HAIC'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Potentially Resection', 'Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': "Hepatocellular carcinoma (HCC) is one of the most commonly malignant tumors around the world. Hepatic resection or liver transplantation is the radical method to cure the disease. However, due to large tumors, surgical treatment is suitable for early-stage and well-reserved liver function patients. Therefore, in clinical practice, transarterial chemoembolization (TACE) is a preferential and standard treatment of potentially resectable HCC.\n\nEACH trial opened the door to FOLFOX-based system chemotherapy for advanced HCC patients. Recently, investigators have showed that hepatic arterial infusion of FOLFOX-based chemotherapy (HAIC) was safe and efficient for HCC patients. Several clinical studies showed that HAIC bring better tumor response rate that the conditional TACE. The combination of TACE with HAIC (TACE-HAIC), theoretically can significantly increase the local doses of chemotherapeutic agents in the liver, reduce the viability of HCC cells and increase the hepatectomy rate. However, this hasn't been verified in clinical application. To identify a more effective and safety way for treating potentially resectable HCC patients, this study is designed to compare the safety and efficacy between HAIC and TACE-HAIC for those patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18-75 years\n* The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)\n* Diagnosed as potentially resectable with consensus by the panel of liver surgeons\n* stage BCLC A/B, without extra-hepatic involvement\n* No previous anti-HCC treatment\n* Eastern Co-operative Group performance status 2 or less\n* Liver function: Child's A or B (score \\< 7)\n\nExclusion Criteria:\n\n* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy\n* underlying serve cardiac or renal diseases\n* Known or suspected allergy to the investigational agent or any agent given in association with this trial\n* Patients ineligible for hepatic artery embolization"}, 'identificationModule': {'nctId': 'NCT03591705', 'briefTitle': 'TACE-HAIC vs. HAIC for Potentially Resectable HCC', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Transarterial Chemoembolization Versus Transarterial Chemoembolization With Hepatic Artery Chemotherapy Infusion for Patients With Potentially Resectable HCC', 'orgStudyIdInfo': {'id': 'B2018-044'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TACE-HAIC', 'description': 'hepatic artery chemo-lipiodolization with EADM, followed by FOLFOX-based chemotherapy artery infusion', 'interventionNames': ['Drug: TACE-HAIC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HAIC', 'description': 'FOLFOX-based chemotherapy hepatic artery infusion', 'interventionNames': ['Drug: HAIC']}], 'interventions': [{'name': 'TACE-HAIC', 'type': 'DRUG', 'description': 'transcatheter arterial chemo-lipiodolization with EADM 30mg/m2, followed by hepatic artery infusion Oxa 85 mg/m2, CF 400 mg/m2, 5-Fu 400 mg/m2, 5-Fu 1200mg/m2 infusion 23h.', 'armGroupLabels': ['TACE-HAIC']}, {'name': 'HAIC', 'type': 'DRUG', 'description': 'hepatic artery infusion Oxa 85 mg/m2, CF 400 mg/m2, 5-Fu 400 mg/m2, 5-Fu 1200mg/m2 infusion 23h.', 'armGroupLabels': ['HAIC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yunfei Yuan', 'role': 'CONTACT', 'email': 'yuanyf@mail.sysu.edu.cn', 'phone': '+862087343118'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Jiliang Qiu', 'role': 'CONTACT', 'email': 'qiujl@sysucc.org.cn', 'phone': '+862087342654'}], 'overallOfficials': [{'name': 'Yunfei Yuan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yunfei Yuan', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}