Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2026-03-03 @ 4:12 PM
Study NCT ID:
NCT03192618
Status:
UNKNOWN
Last Update Posted:
2017-06-20
First Post:
2017-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.
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': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 290}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-19', 'studyFirstSubmitDate': '2017-06-16', 'studyFirstSubmitQcDate': '2017-06-19', 'lastUpdatePostDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free survival (DFS)', 'timeFrame': 'From date of randomization until the date of recurrence, assessed up to 60 months', 'description': 'disease-free survival'}], 'secondaryOutcomes': [{'measure': 'recurrence rate', 'timeFrame': '1 year, 2 year, 3 year, 5 year after surgery', 'description': 'recurrence rate'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'From date of randomization until the date of death from any cause, assessed up to 60 months', 'description': 'overall survival'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'referencesModule': {'references': [{'pmid': '36525610', 'type': 'DERIVED', 'citation': 'Li SH, Mei J, Cheng Y, Li Q, Wang QX, Fang CK, Lei QC, Huang HK, Cao MR, Luo R, Deng JD, Jiang YC, Zhao RC, Lu LH, Zou JW, Deng M, Lin WP, Guan RG, Wen YH, Li JB, Zheng L, Guo ZX, Ling YH, Chen HW, Zhong C, Wei W, Guo RP. Postoperative Adjuvant Hepatic Arterial Infusion Chemotherapy With FOLFOX in Hepatocellular Carcinoma With Microvascular Invasion: A Multicenter, Phase III, Randomized Study. J Clin Oncol. 2023 Apr 1;41(10):1898-1908. doi: 10.1200/JCO.22.01142. Epub 2022 Dec 16.'}, {'pmid': '32418078', 'type': 'DERIVED', 'citation': 'Li S, Mei J, Wang Q, Guo Z, Lu L, Ling Y, Xu L, Chen M, Zheng L, Lin W, Zou J, Wen Y, Wei W, Guo R. Postoperative Adjuvant Transarterial Infusion Chemotherapy with FOLFOX Could Improve Outcomes of Hepatocellular Carcinoma Patients with Microvascular Invasion: A Preliminary Report of a Phase III, Randomized Controlled Clinical Trial. Ann Surg Oncol. 2020 Dec;27(13):5183-5190. doi: 10.1245/s10434-020-08601-8. Epub 2020 May 16.'}]}, 'descriptionModule': {'briefSummary': 'To compare The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* older than 18 years old and younger than 75 years;\n* ECOG PS\\<3;\n* proven hepatocellular carcinoma with MVI according pathological examination;\n* not previous treated for tumor;\n* tumor was removed in operation;\n* no recurrence occurence at 4 to 7 weeks after surgery;\n* the lab test could meet: neutrophil count≥1.5×109/L; hemoglobin≥80g/L; platelet count≥60×109/L; serum albumin≥28g/L; total bilirubin\\<3-times upper limit of normal; ALT\\<5-times upper limit of normal; AST\\<5-times upper limit of normal; serum creatine\\<1.5-times upper limit of normal; PT≤upper limit of normal plus 6 seconds; INR≤2.3;\n* sign up consent;\n* unrolled by other clinical trials about hepatocellular carcinoma.\n\nExclusion Criteria:\n\n* cannot tolerate TAI;\n* CNS or bone metastasis exits;\n* known history of other malignancy;\n* be allergic to related drugs;\n* underwent organ transplantation before;\n* be treated before (interferon included);\n* known history of HIV infection;\n* known history of drug or alcohol abuse;\n* have GI hemorreage or cardiac/brain vascular events within 30 days;\n* pregnancy;'}, 'identificationModule': {'nctId': 'NCT03192618', 'briefTitle': 'The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.', 'orgStudyIdInfo': {'id': 'B2017-006-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment group', 'interventionNames': ['Procedure: adjuvant transarterial chemoinfusion (TAI)', 'Drug: mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)']}, {'type': 'NO_INTERVENTION', 'label': 'control group'}], 'interventions': [{'name': 'adjuvant transarterial chemoinfusion (TAI)', 'type': 'PROCEDURE', 'description': 'transarterial chemoinfusion (TAI) with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)', 'armGroupLabels': ['treatment group']}, {'name': 'mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)', 'type': 'DRUG', 'description': 'oxaliplatin, calcium folinate, and 5-FU', 'armGroupLabels': ['treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '+86', 'city': 'Guangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shaohua Li, MD', 'role': 'CONTACT', 'email': 'lishaoh@sysucc.org.cn', 'phone': '+8615088064187'}], 'facility': 'Cancer Center of Sun Yat-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Shaohua Li, MD', 'role': 'CONTACT', 'email': 'lishaoh@sysucc.org.cn', 'phone': '+8615088064187'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Rong-ping Guo', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}