Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-03-03 @ 6:15 AM
Study NCT ID:
NCT03727633
Status:
RECRUITING
Last Update Posted:
2025-07-10
First Post:
2018-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hepatocellular Carcinoma on Cirrhosis With Child A/B7 and Hepatic Intra Arterial Injection of Idarubicin/Lipiodol Emulsion
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': 'D015255', 'term': 'Idarubicin'}, {'id': 'D004998', 'term': 'Ethiodized Oil'}], 'ancestors': [{'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D007459', 'term': 'Iodized Oil'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking is used. All involved know the identity of the intervention assignment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The purpose of this study is to assess efficacy and tolerance of hepatic intra-arterial injection of an emulsion of Idarubicine and Lipiodol for treatment of non-metastatic, unresectable hepatocellular carcinoma on cirrhosis with Child-Pugh A/B7.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 53}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-01-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-07', 'studyFirstSubmitDate': '2018-05-31', 'studyFirstSubmitQcDate': '2018-10-31', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants presenting a disease control at 4 months', 'timeFrame': '4 months', 'description': 'The primary outcome is to evaluate the disease control rate (partial, complete or stable response) 4 months after the first cycle of chemo-lipiodol using mRECIST criteria.'}], 'secondaryOutcomes': [{'measure': 'Safety of chemo-lipiodol defined by NCI-CTCAE version 4.03', 'timeFrame': '12 months', 'description': 'Safety defined by NCI-CTCAE version 4.03 published 14 june 2010'}, {'measure': 'Objective response rate of chemo-lipiodol', 'timeFrame': '6 months', 'description': 'Objective response rate according to mRECIST at 6 months after the first cycle'}, {'measure': 'best response at 6 months after the first cycle of chemo-lipiodol according to mRECIST', 'timeFrame': '6 months', 'description': 'The best response according to mRECIST at 6 months after the first cycle of chemo-lipiodol'}, {'measure': 'Overall survival', 'timeFrame': '12 months', 'description': 'Overall survival at 12 months after the first cycle of chemo-lipiodol'}, {'measure': 'Quality of life questionnaire (QLQ) QLQ-C30', 'timeFrame': '12 months', 'description': 'Quality of life questionnaire at 12 months after the first cycle of chemo-lipiodol (QLQ-C30). Subscale minimum score is egal to 1 (not at all) and maximum score is egal to 4 (very much). The maximal score correspond to a better quality of life. Subscales are summed to compute a total score.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carcinoma, Hepatocellular']}, 'descriptionModule': {'briefSummary': 'The investigators propose in this trial to test a hepatic chemotherapy, consisting of the hepatic intra-arterial injection Idarubicin, emulsified with Lipiodol, lipid vector, without embolization in the treatment of non-metastatic, unresectable hepatocellular carcinoma on cirrhosis with Child-Pugh A/B7.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically-proven HCC or according to EASL criteria\n* Child-Pugh A or B7\n* Disease that is not suitable for resection, ablation or radiofrequency\n* Performance Status ECOG 0 or 1\n* BCLC A/B or C if Performance Status ECOG = 1\n* Measurable lesions according to mRECIST criteria\n* No previous treatment with chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy) or radioembolisation\n* Age superior or equal to 18 years\n* Platelets \\> 50,000/mm3, Polynuclear neutrophils \\> 1000/mm3, Creatininemia \\< 150umol/L, Bilirubinemia \\< 5 mg/dL\n* Absence of heart failure (Ultrasound LVEF \\> 50%)\n* Women of child-bearing age using an adequate method of contraception throughout treatment\n* Men using an adequate method of contraception throughout the treatment and at least 3 months after the end of treatment\n* Written informed consent\n* National health insurance cover\n\nExclusion Criteria:\n\n* Advanced tumor disease (extrahepatic except pulmonary micronodules \\<7mm of tumoral portal vein thrombosis on positron emission tomography are not a contra-indication.)\n* Large HCC with liver invasion \\>50%\n* History of other cancer than HCC and excluding cancers known to have been cured for more than 5 years, or basocellular skin tumors or cervical cancer in situ treated with adequate and curative purpose\n* Advanced liver disease (Child B8, B9 or C)\n* Contra-indication for the MRI (Pacemaker or neurosensorial stimulator or implantable defibrillator, cochlear implant, ferromagnetic foreing body similar to the nervous structure)\n* Contra-indication to the injection of the gadolinium-based contrast agents (history of hypersensibility to the gadolinium chelates, meglumine).\n* Contra-indication to idarubicin (Hypersensibility to active substance or excipients, cardiopathy with myocardial insufficiency of less than 6 months, serious arrhythmias, serious renal or liver failure, yellow fever vaccine or any other live attenuated vaccine, persistente myelosuppression, previous treatments with idarubicin and/or other anthracyclines or anthracenediones at maximum cumulative doses, stomatitis)\n* Contra-indication to Lipiodol (Hypersensibility, proven hyperthyroidism, tromatic injuries, bleeding or recent bleeding)\n* Concomitant disease or uncontrolled severe clinical situation\n* Uncontrolled severe infection\n* Vascular anatomy makes it impossible to perform hepatic intra-arterial treatments\n* Pregnancy (Beta HCG positive) or breastfeeding\n* Patient who for psychological, social, family or geographical reasons cannot be followed regularly\n* Vulnerable person\n* Concomitant participation of the patient in another research involving the human person'}, 'identificationModule': {'nctId': 'NCT03727633', 'acronym': 'LIDA-BII', 'briefTitle': 'Hepatocellular Carcinoma on Cirrhosis With Child A/B7 and Hepatic Intra Arterial Injection of Idarubicin/Lipiodol Emulsion', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': "Traitement Des Carcinomes hépatocellulaires Sur Cirrhose Child A/B7 Par Injection Intra-artérielle hépatique d'Une émulsion de Lipiodol et Idarubicine : Etude de Phase II, Monobras, Multicentrique.", 'orgStudyIdInfo': {'id': 'RECHMPL17_0304'}, 'secondaryIdInfos': [{'id': '2017-004859-22', 'type': 'EUDRACT_NUMBER'}, {'id': 'UF 9888', 'type': 'OTHER', 'domain': 'Montpellier University Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment arm', 'description': 'hepatic intra-arterial injection of an emulsion of Idarubicine and Lipiodol', 'interventionNames': ['Drug: Idarubicin and Lipiodol']}], 'interventions': [{'name': 'Idarubicin and Lipiodol', 'type': 'DRUG', 'description': 'Hepatic intra-arterial chemotherapy consisting of the hepatic intra-arterial injection Idarubicin, emulsified with Lipiodol', 'armGroupLabels': ['Treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christophe AUBE, PH', 'role': 'CONTACT'}], 'facility': "CHU d'Angers", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '21079', 'city': 'Dijon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Romaric LOFFROY, PH', 'role': 'CONTACT'}], 'facility': 'CHU de Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '34295', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Boris GUIU, PUPH', 'role': 'CONTACT'}], 'facility': 'CHU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '06202', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Patrick CHEVALLIER, PH', 'role': 'CONTACT'}], 'facility': 'CHU de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'Boris GUIU, MD', 'role': 'CONTACT', 'email': 'b-guiu@chu-montpellier.fr', 'phone': '04 67 33 75 46'}], 'overallOfficials': [{'name': 'Boris GUIU', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montpellier University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'collaborators': [{'name': 'Guerbet', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}