Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-01-31 @ 3:53 PM
Study NCT ID:
NCT00562666
Status:
TERMINATED
Last Update Posted:
2012-06-22
First Post:
2007-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunotherapy of Hepatocellular Carcinoma With Gamma Delta T Cells
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-21', 'studyFirstSubmitDate': '2007-11-21', 'studyFirstSubmitQcDate': '2007-11-21', 'lastUpdatePostDateStruct': {'date': '2012-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Onset of: thrombosis of hepatic artery, grade 4 liver toxicity, or grade 3 or more allergic, neurological, dermatological, infectious, or respiratory reaction', 'timeFrame': 'Within 14 days after treatment'}], 'secondaryOutcomes': [{'measure': 'Onset of clinical, biological signs or images evocative of lymphocyte-induced tumor cytotoxicity and/or of a persistence of gamma-delta T cells in peripheral blood. Tumor response will be evaluated with the RECIST criteria.', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cell therapy', 'T lymphocytes', 'hepatic intra-arterial injection'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'For most patients with hepatocellular carcinoma, surgery or other curative procedures are not possible and only palliative measures could be applied (chemoembolization, targeted drugs, best supportive cares, etc). In the ICAR study, increasing doses of a cell therapy product will be evaluated in patients in a palliative setting. All patients will have one hepatic intra-arterial injection of immunological cells (gamma-delta T lymphocytes) and will be evaluated for safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult over 18\n* Hepatocellular carcinoma histologically proven, with at least one measurable tumor\n* Non operable tumor\n* Alfa foeto protein \\> 400 ng/ml\n* Other treatments (surgery, chemoembolization) non indicated\n* Chemoembolization non indicated due to good performance status (WHO 1) or to tumor volume\n* Performance status WHO \\< 2\n* Life expectancy \\> 3 months\n\nNon inclusion Criteria:\n\n* Extra hepatic metastases\n* Severe hepatopathy (Child B or C)\n* Virus B or C chronic hepatitis\n* Chronic cardiac failure\n* Uncontrolled severe infectious disease\n* Other cancer, if not considered as cured\n* Positive serology for HIV or HTLV\n* Leucocytes \\< 3000/mm3 or neutrophils \\< 1500/mm3\n* Platelets \\< 80000/mm3\n* Serum creatinine \\> 110 µmol/L\n* Bilirubin \\> 35 µmol/L\n* AST, ALT, alkaline phosphatase \\> 5N\n* Current immunosuppressive treatment\n* Impossibility to comply with scheduled follow-up\n* Anatomical situation not permitting the selective injection of the product of cell therapy\n* Pregnant or breastfeeding woman, or not using adequate effective contraceptive method\n\nExclusion Criterion:\n\n* Insufficient number of gamma delta lymphocytes after expansion'}, 'identificationModule': {'nctId': 'NCT00562666', 'acronym': 'ICAR', 'briefTitle': 'Immunotherapy of Hepatocellular Carcinoma With Gamma Delta T Cells', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Immunotherapy of Hepatocellular Carcinoma by Hepatic Intra Arterial Injection of Autologous Gamma-delta T Lymphocytes: A Phase I Study', 'orgStudyIdInfo': {'id': 'ID RCB 2007-A00249-44'}, 'secondaryIdInfos': [{'id': 'CIC 0203/074'}, {'id': 'LOC 06/07'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Single hepatic intra arterial administration of 500 millions T gamma delta lymphocytes', 'interventionNames': ['Other: T gamma delta lymphocytes']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Single hepatic intra arterial administration of 1000 millions T gamma delta lymphocytes', 'interventionNames': ['Other: T gamma delta lymphocytes']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Single hepatic intra arterial administration of 2000 millions T gamma delta lymphocytes', 'interventionNames': ['Other: T gamma delta lymphocytes']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'Single hepatic intra arterial administration of 4000 millions T gamma delta lymphocytes', 'interventionNames': ['Other: T gamma delta lymphocytes']}], 'interventions': [{'name': 'T gamma delta lymphocytes', 'type': 'OTHER', 'description': 'Single hepatic intra arterial administration of increasing doses of T gamma delta lymphocytes', 'armGroupLabels': ['1', '2', '3', '4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35000', 'city': 'Rennes', 'country': 'France', 'facility': 'Unité de Thérapie Cellulaire, Laboratoire de Cytogénétique et Biologie Cellulaire, CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '35042', 'city': 'Rennes', 'country': 'France', 'facility': "Département d'Oncologie Médicale - CRLCC Eugène Marquis", 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rennes', 'country': 'France', 'facility': 'Service de Chirugie Viscérale - Hôpital de Pontchaillou', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'overallOfficials': [{'name': 'Jean-Luc RAOUL, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CRLCC Eugène Marquis, Rennes'}, {'name': 'Eric BELLISSANT, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Rennes University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Innate Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}