Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-02 @ 3:04 PM
Study NCT ID:
NCT03732235
Status:
UNKNOWN
Last Update Posted:
2019-02-21
First Post:
2018-10-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TACE Associated to Systemic Bevacizumab for the Treatment of Refractory Liver Metastases From Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-19', 'studyFirstSubmitDate': '2018-10-30', 'studyFirstSubmitQcDate': '2018-11-05', 'lastUpdatePostDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to progression', 'timeFrame': '1 year', 'description': 'time from first treatment to progression will be computed'}], 'secondaryOutcomes': [{'measure': 'Tumor response', 'timeFrame': '3 months', 'description': 'CT scan will be performed to assess tomuor response'}, {'measure': 'Number of adverse events', 'timeFrame': '3 motnhs', 'description': 'Number of adverse events will be monitored'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Liver Metastases', 'Transarterial chemoembolization', 'Bevacizumab', 'Anti-angiogenesis', 'Irinotecan', 'Embolics', 'FOLFIRI'], 'conditions': ['Liver Metastasis Colon Cancer']}, 'referencesModule': {'references': [{'pmid': '32111770', 'type': 'DERIVED', 'citation': 'Fiorentini G, Sarti D, Nardella M, Inchingolo R, Nestola M, Rebonato A, Guadagni S. Chemoembolization Alone or Associated With Bevacizumab for Therapy of Colorectal Cancer Metastases: Preliminary Results of a Randomized Study. In Vivo. 2020 Mar-Apr;34(2):683-686. doi: 10.21873/invivo.11824.'}]}, 'descriptionModule': {'briefSummary': 'Transarterial chemoembolization (TACE) is an effective, minimally invasive therapy that is widely used for unresectable colorectal cancer liver metastases (CRC-LM) treatment. Chemoembolization, however, induces a hypoxic micro-environment, which increases neo-angiogenesis, and may promote early progression. For this reason, efficacy may be improved by associating TACE with an angiogenesis inhibitor, such as bevacizumab.\n\nThe use of FOLFIRI associate to Bevacizumab is part of clinical practice and is commonly used for the therapy of patients with CRC-LM both wild type and mutant.\n\nThis case-control observational study aim to compare patients treated with TACE using Irinotecan-loaded embolics followed by systemic Bevacizumab versus patients treated with FILFIRI+ Bevacizumab', 'detailedDescription': 'TACE is indicated for the treatment of unresectable CRC\\_LM, patients who are refractory to systemic chemotherapy, elderly, or have a poor performance status, and is usually performed using irinotecan (IRI) covalently loaded onto embolics.\n\nAlthough chemoembolization with irinotecan-loaded embolics results in an objective response, this method creates a hypoxic micro-environment. Hypoxia induces and activates the HIF-1 and HIF 2 hypoxia-inducible transcription factors, which promote high-level VEGF expression and subsequent neo-angiogenesis.\n\nThis may provide a mechanism for early relapse and progression following TACE and strongly support a rational for following TACE therapy with a therapeutic inhibitor of angiogenesis, such as bevacizumab.\n\nThe use of FOLFIRI associate to Bevacizumab is part of clinical practice and is commonly used for the therapy of patients with CRC-LM both wild type and mutant.\n\nThis case-control observational study aim to compare patients treated with TACE using Irinotecan-loaded embolics followed by systemic Bevacizumab versus patients treated with FILFIRI+ Bevacizumab'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This was a prospective observational single center study.that involved CRC-LM patients treated with TACE, using irinotecan-loaded PEG embolics (LIFIRI), followed by the intravenous administration of bevacizumab. This group was compared to CRC-LM patients treated with FOLFIRI+Bevacizumab.\n\nCRC-LM patients were instructed by physician about the study procedures and after signing informed consent choose the type of theratment TACE+bevacizumab or FOLOFIRI+bevacizumab', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent\n* \\>18 years old;\n* diagnosed with unresectable CRC-LM (for reasons of anatomy, co-morbidity, patient's wishes, lack of response to standard therapy with intravenous or oral fluoropyrimidine, oxaliplatin, irinotecan or biological agents (bevacizumab, cetuximab, panitumumab);\n* Eastern Cooperative Oncology Group (ECOG) 0-1;\n* measurable tumor size by mRECIST \\[6\\];\n* ≤40% liver involvement;\n* a life expectancy of at least 3 months,\n* blood biochemistry within the normal range.\n\nExclusion Criteria:\n\n* contraindication for angiographic catheterization;\n* extensive extra-hepatic disease;\n* pregnancy or breast-feeding,\n* other severe clinical contraindications (e.g. liver failure, ascites, cardiovascular diseases and/or chronic obstructive pulmonary disease)."}, 'identificationModule': {'nctId': 'NCT03732235', 'acronym': 'EMBOBEVA', 'briefTitle': 'TACE Associated to Systemic Bevacizumab for the Treatment of Refractory Liver Metastases From Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'International Group of Endovascular Oncology'}, 'officialTitle': 'Observational Study on Transarterial Chemoembolization With Irinotecan-loaded Embolics Associated With Systemic Bevacizumab for the Treatment of Refractory Liver Metastases From Colorectal Cancer', 'orgStudyIdInfo': {'id': 'EMBOBEVA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TACE+ systemic Bevacizumab', 'description': 'TACE was performed, using 2 ml of LifePearl® with 100 micron diameter (Terumo Europe NV, Leuven, Belgium) loaded with Irinotecan (100 mg), diluted in 5 ml of non-ionic contrast solution and 5 ml of distilled water, infused at fixed speed of 1ml/minute for a median time of 12 minutes (range 8-16 minutes). A second TACE was performed after 30 days if needed according to physician choice.\n\nBevacizumab (5 mg/kg) therapy was initiated 15 days after first round of TACE and was repeated every two weeks, for a total of 8 cycles.', 'interventionNames': ['Device: TACE+ systemic Bevacizumab']}, {'label': 'FOLFIRI+Bevacizumab', 'description': 'FOLFIRI consists of 5-FU administered as a 48-hour continuous infusion to a total dose of 3,200 mg/m2 without a bolus, leucovorin 200 mg/m2, irinotecan 165 mg/m2 Bevacizumab (5 mg/kg) therapy was repeated every two weeks, for a total of 8 cycles.', 'interventionNames': ['Drug: FOLFIRI+Bevacizumab']}, {'label': 'TACE', 'description': 'TACE was performed, using 2 ml of LifePearl® with 100 micron diameter (Terumo Europe NV, Leuven, Belgium) loaded with Irinotecan (100 mg), diluted in 5 ml of non-ionic contrast solution and 5 ml of distilled water, infused at fixed speed of 1ml/minute for a median time of 12 minutes (range 8-16 minutes). A second TACE was performed after 30 days if needed according to physician choice.', 'interventionNames': ['Device: TACE']}], 'interventions': [{'name': 'TACE+ systemic Bevacizumab', 'type': 'DEVICE', 'description': 'PEG embolics', 'armGroupLabels': ['TACE+ systemic Bevacizumab']}, {'name': 'FOLFIRI+Bevacizumab', 'type': 'DRUG', 'description': 'antiangiogenic factor', 'armGroupLabels': ['FOLFIRI+Bevacizumab']}, {'name': 'TACE', 'type': 'DEVICE', 'description': 'PEG embolics', 'armGroupLabels': ['TACE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61122', 'city': 'Pesaro', 'state': 'PU', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giammaria Fiorentini, MD', 'role': 'CONTACT', 'email': 'giammaria.fiorentini@ospedalimarchenord.it', 'phone': '+390721364124'}, {'name': 'Giammaria Fiorentini, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio Ospedaliero San Salvatore', 'geoPoint': {'lat': 43.90921, 'lon': 12.9164}}], 'centralContacts': [{'name': 'Giammaria Fiorentini, MD', 'role': 'CONTACT', 'email': 'g.fiorentini@alice.it', 'phone': '+390721364005'}, {'name': 'Donatella Sarti, PhD', 'role': 'CONTACT', 'email': 'd.sarti@fastwebnet.it', 'phone': '+390721364018'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '1 year', 'ipdSharing': 'YES', 'description': 'Study protocol will be shared', 'accessCriteria': 'request by email to Principal Investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Giammaria Fiorentini', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Giammaria Fiorentini', 'investigatorAffiliation': 'International Group of Endovascular Oncology'}}}}