Ignite Creation Date:
2025-12-24 @ 2:10 PM
Ignite Modification Date:
2026-01-14 @ 4:30 PM
Study NCT ID:
NCT03775395
Status:
UNKNOWN
Last Update Posted:
2019-01-03
First Post:
2018-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HAIC Plus Lenvatinib vs HAIC Plus Sorafenib for Advanced 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': 'C531958', 'term': 'lenvatinib'}, {'id': 'D000077157', 'term': 'Sorafenib'}], 'ancestors': [{'id': 'D010671', 'term': 'Phenylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009536', 'term': 'Niacinamide'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-01', 'studyFirstSubmitDate': '2018-12-12', 'studyFirstSubmitQcDate': '2018-12-12', 'lastUpdatePostDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Time Frame: 12 months', 'description': 'Overall survival'}], 'secondaryOutcomes': [{'measure': 'Time to progression', 'timeFrame': 'Time Frame: 12 months', 'description': 'Time to progression'}, {'measure': 'Adverse Events', 'timeFrame': '[Time Frame: 30 days]'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Time Frame: 12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatocellular carcinoma', 'Hepatic artery infusion chemotherapy', 'Sorafenib', 'Lenvatinib'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) compared with lenvatinib combined with HAIC in patients with advanced hepatocellular carcinoma (HCC)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\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* Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.\n* Barcelona clinic liver cancer-stage C\n* Eastern Cooperative Oncology Group performance status of 0 to 2\n* with no previous treatment\n* No Cirrhosis or cirrhotic status of Child-Pugh class A only\n* Not amendable to surgical resection ,local ablative therapy and any other cured treatment.\n* The following laboratory parameters:\n* Platelet count ≥ 75,000/μL\n* Hemoglobin ≥ 8.5 g/dL\n* Total bilirubin ≤ 30mmol/L\n* Serum albumin ≥ 30 g/L\n* ASL and AST ≤ 5 x upper limit of normal\n* Serum creatinine ≤ 1.5 x upper limit of normal\n* INR ≤ 1.5 or PT/APTT within normal limits\n* Absolute neutrophil count (ANC) \\>1,500/mm3\n* Ability to understand the protocol and to agree to and sign a written informed consent document\n\nExclusion Criteria:\n\n* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy\n* Known history of HIV\n* History of organ allograft\n* Known or suspected allergy to the investigational agents or any agent given in association with this trial.\n* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy\n* Evidence of bleeding diathesis.\n* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.\n* Known central nervous system tumors including metastatic brain disease'}, 'identificationModule': {'nctId': 'NCT03775395', 'briefTitle': 'HAIC Plus Lenvatinib vs HAIC Plus Sorafenib for Advanced HCC', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Hepatic Artery Infusion Chemotherapy Plus Lenvatinib vs Hepatic Artery Infusion Chemotherapy Plus Sorafenib for Advanced Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'HCC-S055'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HAIC plus Lenvatinib', 'interventionNames': ['Drug: Lenvatinib', 'Procedure: Hepatic arterial infusion chemotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HAIC plus Sorafenib', 'interventionNames': ['Drug: Sorafenib', 'Procedure: Hepatic arterial infusion chemotherapy']}], 'interventions': [{'name': 'Lenvatinib', 'type': 'DRUG', 'description': '12 mg (or 8 mg) once daily (QD) oral dosing.', 'armGroupLabels': ['HAIC plus Lenvatinib']}, {'name': 'Sorafenib', 'type': 'DRUG', 'description': '400mg BID daily oral dosing', 'armGroupLabels': ['HAIC plus Sorafenib']}, {'name': 'Hepatic arterial infusion chemotherapy', 'type': 'PROCEDURE', 'description': 'administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries', 'armGroupLabels': ['HAIC plus Lenvatinib', 'HAIC plus Sorafenib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ming Shi, MD', 'role': 'CONTACT', 'email': 'shiming@mail.sysu.edu.cn', 'phone': '8620-87343115'}], 'facility': 'Cancer Center Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Ming Shi, MD', 'role': 'CONTACT', 'email': 'shiming@sysucc.org.cn', 'phone': '+862087343938'}], 'overallOfficials': [{'name': 'Ming Shi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Shi Ming', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}