Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-31 @ 11:25 PM
Study NCT ID:
NCT03780634
Status:
WITHDRAWN
Last Update Posted:
2019-05-06
First Post:
2018-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HAIC Plus PD-1 Antibody 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': 'C000711728', 'term': 'spartalizumab'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No participants enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-02', 'studyFirstSubmitDate': '2018-12-18', 'studyFirstSubmitQcDate': '2018-12-18', 'lastUpdatePostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': '12 months', 'description': 'PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1), or date of death, whichever occurred first.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': '12 months', 'description': 'OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': '12 months', 'description': 'ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on RECIST.'}, {'measure': 'Adverse Events', 'timeFrame': '12 months', 'description': 'Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.03'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatocellular Carcinoma', 'Hepatic arterial infusion chemotherapy', 'Programmed cell death protein-1 antibody', 'Oxaliplatin, 5-Fluorouracil and Leucovorin'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of hepatic artery infusion chemotherapy (HAIC) combined with Programmed Cell Death Protein-1 (PD-1) antibody compared with HAIC plus sorafenib in patients with advanced hepatocellular carcinoma (HCC)', 'detailedDescription': 'The results of our preliminary pilot study suggested that sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for advanced hepatocellular (HCC). Programmed Cell Death Protein-1 (PD-1) antibody has been proved effective and safety for advanced HCC. There is no study about HAIC plus PD-1 antibody. Thus, the investigators carried out this prospective randomized control study to compare HAIC plus sorafenib and HAIC plus PD-1 antibody.'}, '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* Major portal vein tumor thrombus (Vp3,Vp4)\n* Eastern Cooperative Oncology Group performance status of 0 to 1\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\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': 'NCT03780634', 'briefTitle': 'HAIC Plus PD-1 Antibody vs HAIC Plus Sorafenib for Advanced HCC', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Hepatic Artery Infusion Chemotherapy Plus Programmed Cell Death Protein-1 (PD-1) Antibody vs Hepatic Artery Infusion Chemotherapy Plus Sorafenib for Advanced Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'HCC-S059'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HAIC plus PD-1 antibody', 'description': 'Participants received PD-1 antibody intravenously and hepatic artery infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin every 3 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.', 'interventionNames': ['Procedure: HAIC', 'Drug: PD-1 antibody']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HAIC plus sorafenib', 'description': 'Participants received sorafenib capsules 400mg bid in continuous 21-day treatment cycles, and received hepatic artery infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin every 3 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.', 'interventionNames': ['Procedure: HAIC', 'Drug: Sorafenib']}], 'interventions': [{'name': 'HAIC', 'type': 'PROCEDURE', 'description': 'administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks', 'armGroupLabels': ['HAIC plus PD-1 antibody', 'HAIC plus sorafenib']}, {'name': 'PD-1 antibody', 'type': 'DRUG', 'otherNames': ['Programmed cell death 1 antibody'], 'description': '200mg intravenously every 3 weeks', 'armGroupLabels': ['HAIC plus PD-1 antibody']}, {'name': 'Sorafenib', 'type': 'DRUG', 'description': '400 mg Bid Po', 'armGroupLabels': ['HAIC plus sorafenib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Cancer Center Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510620', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': "Guangzhou Twelfth People 's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '529300', 'city': 'Kaiping', 'state': 'Guangdong', 'country': 'China', 'facility': 'Kaiping Central Hospital', 'geoPoint': {'lat': 22.572, 'lon': 113.88578}}], 'overallOfficials': [{'name': 'Ming Shi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kaiping Central Hospital', 'class': 'OTHER'}, {'name': "Guangzhou No.12 People's Hospital", 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Proffessor', 'investigatorFullName': 'Shi Ming', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}