Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-01-07 @ 1:31 PM
Study NCT ID:
NCT03368651
Status:
RECRUITING
Last Update Posted:
2017-12-11
First Post:
2017-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) Who Underwent 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 230}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-08', 'studyFirstSubmitDate': '2017-12-04', 'studyFirstSubmitQcDate': '2017-12-08', 'lastUpdatePostDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'measure': 'recurrence-free survival (RFS)', 'timeFrame': 'From date of randomization until the date of recurrence, assessed up to 60 months', 'description': 'recurrence-free survival'}, {'measure': 'recurrence rate', 'timeFrame': '1 year, 2 year, 3 year, 5 year after surgery', 'description': 'recurrence rate'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'To compare the impact on survival of neo-adjuvant TAI for patients with HCC and PVTT who underwent 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≤1;\n* proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;\n* not previous treated for tumor;\n* estimated tumor and tumor thrombosis could be removed en bloc in operation;\n* no distant metastasis;\n* the lab test could meet: neutrophil count≥2.0×109/L; hemoglobin≥100g/L; platelet count≥75×109/L; serum albumin≥35g/L; total bilirubin\\<2-times upper limit of normal; ALT\\<3-times upper limit of normal; AST\\<3-times upper limit of normal; serum creatine\\<1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds; INR≤2.2;\n* sign up consent;\n\nExclusion Criteria:\n\n* cannot tolerate TAI or surgery;\n* distant 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 hemorrhage or cardiac/brain vascular events within 30 days;\n* pregnancy;'}, 'identificationModule': {'nctId': 'NCT03368651', 'briefTitle': 'The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) Who Underwent Hepatectomy : A Random, Controlled, Stage III Clinical Trial.', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) Who Underwent Hepatectomy : A Random, Controlled, Stage III Clinical Trial.', 'orgStudyIdInfo': {'id': 'B2017-076-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment group', 'description': 'transarterial chemoinfusion (TAI) with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)', 'interventionNames': ['Procedure: TAI']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'no neo-adjuvant treatment before operation'}], 'interventions': [{'name': 'TAI', 'type': 'PROCEDURE', 'description': 'transarterial chemoinfusion with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)', 'armGroupLabels': ['treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '+86', 'city': 'Guangzhou', 'state': 'Guangdong', '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'}}}}