Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-03-06 @ 1:21 AM
Study NCT ID:
NCT02291133
Status:
COMPLETED
Last Update Posted:
2021-07-23
First Post:
2014-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Primary Liver Tumors With Electrochemotherapy (ECT)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053672', 'term': 'Electrochemotherapy'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000092722', 'term': 'Electroporation Therapies'}, {'id': 'D018274', 'term': 'Electroporation'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D055664', 'term': 'Electrochemical Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gsersa@onko-i.si', 'phone': '+38615874343', 'title': 'Dr Gregor Serša', 'organization': 'Institute of Oncology Ljubljana'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '7, 30, 60, 90, 120 days', 'eventGroups': [{'id': 'EG000', 'title': 'Electrochemotherapy Treatment', 'description': 'Electrochemotherapy: Exploration, anesthesia, adhesiolysis, mobilization of liver, intra-operative US or CT, bleomycin administration, electroporation\n\nCliniporator Vitae®: Positioning of electrodes, 8-28 min after administration of bleomycin application of electric pulses (8 pulses, duration 100 microseconds, frequency 8 Hz with amplitude adequate to cover the whole treated lesion with electric field necessary for reversible plasma membrane permeabilization), removal of electrodes.\n\nThe maximum duration of procedure is 90 minutes, after liver mobilization.\n\nBleomycin PHC 15 e. (United States Pharmacopeia - USP): Intravenous in bolus administration of bleomycin (15 mg/m2)', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 15, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Clavien-Dindo Classification, Grade I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Clavien-Dindo Classification, Grade II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Toxicity Related to Electrochemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electrochemotherapy Treatment', 'description': 'Electrochemotherapy: Exploration, anesthesia, adhesiolysis, mobilization of liver, intra-operative US or CT, bleomycin administration, electroporation\n\nCliniporator Vitae®: Positioning of electrodes, 8-28 min after administration of bleomycin application of electric pulses (8 pulses, duration 100 microseconds, frequency 8 Hz with amplitude adequate to cover the whole treated lesion with electric field necessary for reversible plasma membrane permeabilization), removal of electrodes.\n\nThe maximum duration of procedure is 90 minutes, after liver mobilization.\n\nBleomycin PHC 15 e. (United States Pharmacopeia - USP): Intravenous in bolus administration of bleomycin (15 mg/m2)'}], 'classes': [{'categories': [{'title': 'No adverse events', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': 'ECT-related adverse events', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Non-ECT-related within 24 h', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Non-ECT-related after 24 h', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After operation on day 7', 'description': 'Biochemistry, blood test and/or US', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Response Evaluation According to RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electrochemotherapy Treatment', 'description': 'Electrochemotherapy: Exploration, anesthesia, adhesiolysis, mobilization of liver, intra-operative US or CT, bleomycin administration, electroporation\n\nCliniporator Vitae®: Positioning of electrodes, 8-28 min after administration of bleomycin application of electric pulses (8 pulses, duration 100 microseconds, frequency 8 Hz with amplitude adequate to cover the whole treated lesion with electric field necessary for reversible plasma membrane permeabilization), removal of electrodes.\n\nThe maximum duration of procedure is 90 minutes, after liver mobilization.\n\nBleomycin PHC 15 e. (United States Pharmacopeia - USP): Intravenous in bolus administration of bleomycin (15 mg/m2)'}], 'classes': [{'categories': [{'title': 'complete response (CR)', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'partial response (PR)', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'stable disease (SD)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'progressive disease (PD)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After operation on days 1, 7, 30, 60, 90, 120', 'description': 'Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI/CT:\n\nComplete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Electrochemotherapy Treatment', 'description': 'Electrochemotherapy: Exploration, anesthesia, adhesiolysis, mobilization of liver, intra-operative US or CT, bleomycin administration, electroporation\n\nCliniporator Vitae®: Positioning of electrodes, 8-28 min after administration of bleomycin application of electric pulses (8 pulses, duration 100 microseconds, frequency 8 Hz with amplitude adequate to cover the whole treated lesion with electric field necessary for reversible plasma membrane permeabilization), removal of electrodes.\n\nThe maximum duration of procedure is 90 minutes, after liver mobilization.\n\nBleomycin PHC 15 e. (United States Pharmacopeia - USP): Intravenous in bolus administration of bleomycin (15 mg/m2)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Electrochemotherapy Treatment', 'description': 'Electrochemotherapy: Exploration, anesthesia, adhesiolysis, mobilization of liver, intra-operative US or CT, bleomycin administration, electroporation\n\nCliniporator Vitae®: Positioning of electrodes, 8-28 min after administration of bleomycin application of electric pulses (8 pulses, duration 100 microseconds, frequency 8 Hz with amplitude adequate to cover the whole treated lesion with electric field necessary for reversible plasma membrane permeabilization), removal of electrodes.\n\nThe maximum duration of procedure is 90 minutes, after liver mobilization.\n\nBleomycin PHC 15 e. (United States Pharmacopeia - USP): Intravenous in bolus administration of bleomycin (15 mg/m2)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.6', 'groupId': 'BG000', 'lowerLimit': '52', 'upperLimit': '78'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-11-06', 'size': 865831, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2021-07-02T04:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-02', 'studyFirstSubmitDate': '2014-11-06', 'resultsFirstSubmitDate': '2021-06-11', 'studyFirstSubmitQcDate': '2014-11-11', 'lastUpdatePostDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-02', 'studyFirstPostDateStruct': {'date': '2014-11-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Toxicity Related to Electrochemotherapy', 'timeFrame': 'After operation on day 7', 'description': 'Biochemistry, blood test and/or US'}], 'secondaryOutcomes': [{'measure': 'Clinical Response Evaluation According to RECIST v1.1', 'timeFrame': 'After operation on days 1, 7, 30, 60, 90, 120', 'description': 'Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI/CT:\n\nComplete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Primary liver tumors', 'Bleomycin', 'Electrochemotherapy'], 'conditions': ['Liver Cancer']}, 'referencesModule': {'references': [{'pmid': '24782355', 'type': 'BACKGROUND', 'citation': 'Edhemovic I, Brecelj E, Gasljevic G, Marolt Music M, Gorjup V, Mali B, Jarm T, Kos B, Pavliha D, Grcar Kuzmanov B, Cemazar M, Snoj M, Miklavcic D, Gadzijev EM, Sersa G. Intraoperative electrochemotherapy of colorectal liver metastases. J Surg Oncol. 2014 Sep;110(3):320-7. doi: 10.1002/jso.23625. Epub 2014 Apr 30.'}]}, 'descriptionModule': {'briefSummary': "The aim of the study is to evaluate toxicity and effectiveness of electrochemotherapy with bleomycin in treatment of primary liver tumors in clinical study phase I and II.\n\nThe study will include 10 patients in phase I clinical study and additional 15 patients in phase II clinical study (or in the extension of the clinical study), which will fulfill inclusion criteria.\n\nTreatment effectiveness will be evaluated by DCE-US or CT perfusion, to detect early events in tumor perfusion after ECT compared to tumor perfusion before ECT. Long term effectiveness of the treatment will be evaluated by modified RECIST criteria, which will take into account difference in size and density, determined from images obtained by CT perfusion of the treated tumor nodules before and after ECT. Tumor volume will be calculated by following formula , where a will be shorter and b longer tumor diameter.\n\nThe secondary objectives of the trial are to quantify the impact of the treatment on the patient's quality of life, tolerance to the therapy and suitability for larger study to be conducted.", 'detailedDescription': 'The study will be conducted on patients with primary liver tumors. 10 patients will be included in phase I clinical study and additional 15 patients in phase II clinical study (or in the extension of the clinical study).\n\nDepending on the position of tumors, appropriate electrodes will be selected; hexagonal needle electrodes with fixed geometry for tumors not larger than 3 cm in diameter, where lower edge of the tumor is located up to 3 cm below the liver capsule or longer single needle electrodes. Individual electrodes, positioned according to the prepared treatment plan will be used for tumors up to 7 cm in diameter, or located near vena cava or large hepatic or portal veins.\n\nElectrochemotherapy will be performed within 8-28 min after intravenous in bolus administration of bleomycin (15 mg/m2).\n\nTriggering of electric pulses will be synchronized with ECG signals, through the ECG triggering device AccuSync to avoid delivery of pulses in vulnerable period of the heart.\n\nAll patients will be treated after the procedure has been thoroughly described to them, and have signed informed consent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with primary liver tumors; hepatocellular carcinoma, intrahepatic cholangiocarcinoma and other primary tumors not larger than 7 cm that are positioned in unresectable liver area, near blood vessels in operable patients.\n2. Patients with the progression of the disease (confirmed by radiological imaging) after treatment with TACE, RFA or percutaneous alcohol ablation, which are not suitable for potentially curative treatment, but with relatively good "performance status" and Child-Pugh score \\< 8.\n\n Patients from group 1. and 2. are patients, in whom standard treatment procedures are not eligible, so ECT will be the only therapeutic option. In patients with multiple liver tumors, unresectable tumors which are also unsuitable for RAF will be treated by ECT, whereas other tumors will be resected or treated by RAF.\n3. Patients with tumors smaller tumors, not suitable for liver transplantation, but also unsuitable for RFA treatment or percutaneous alcohol ablation because of the position of the tumor. Electrochemotherapy will be as bridge therapy, till liver transplantation.\n4. Patients with tumors\\> 4 cm in diameter, in difficult to reach locations, and patients unsuitable for treatment with other treatment options.\n\n Patients from group 3. and 4. are patients, potentially curable with standard treatment. Electrochemotherapy in these patients will not affect the standard of care of these patients, recommended in guidelines for HCC.\n5. Electrochemotherapy is offered to the patients also when they refuse standard treatments.\n6. Histologically confirmed primary liver cancer and/or based on radiological imaging laboratory tests confirmed primary liver cancer by multidisciplinary team for liver tumors.\n7. Age more than 18.\n8. Life expectancy more than 3 month.\n9. Performance status Karnofsky ≥ 70 or (World Health Organization) WHO \\< or 2.\n10. Treatment free interval 2-5 weeks, depending on the drugs used.\n11. Patient must be mentally capable of understanding the information given.\n12. Patient must give informed consent.\n13. Patient must be discussed at the multidisciplinary team for liver tumors before entering the trial.\n\nExclusion Criteria:\n\n1. Secondary primary tumor, except surgically treated noninvasive cancer of cervix, or surgically or irradiated basal cell carcinoma\n2. Visceral, bone or diffuse metastases.\n3. Life-threatening infection and/or heart failure and/or liver failure and/or other severe systemic pathologies.\n4. Clinically significant ascites.\n5. Significant reduction in respiratory function.\n6. Age less than 18 years.\n7. Coagulation disturbances (those who do not respond on standard treatment with vitamin-K or fresh frozen plasma).\n8. Cumulative dose of 250 mg/m2 bleomycin received.\n9. Allergic reaction to bleomycin.\n10. Impaired kidney function (creatinin \\> 150 µmol/l).\n11. Patients with epilepsy.\n12. Patients with arrhythmias.\n13. Patients with heart failure or pace maker.\n14. Pregnancy.\n15. Patient incapable of understanding the aim of the study or disagree with the entering into the clinical study.'}, 'identificationModule': {'nctId': 'NCT02291133', 'acronym': 'ECT-HCC', 'briefTitle': 'Treatment of Primary Liver Tumors With Electrochemotherapy (ECT)', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'officialTitle': 'Treatment of Primary Liver Tumors With Electrochemotherapy (ECT)', 'orgStudyIdInfo': {'id': '21K/02/14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electrochemotherapy treatment', 'interventionNames': ['Procedure: Electrochemotherapy', 'Device: Cliniporator Vitae®', 'Drug: Bleomycin PHC 15 e. (United States Pharmacopeia - USP)']}], 'interventions': [{'name': 'Electrochemotherapy', 'type': 'PROCEDURE', 'description': 'Exploration, anesthesia, adhesiolysis, mobilization of liver, intra-operative US or CT, bleomycin administration, electroporation', 'armGroupLabels': ['Electrochemotherapy treatment']}, {'name': 'Cliniporator Vitae®', 'type': 'DEVICE', 'description': 'Positioning of electrodes, 8-28 min after administration of bleomycin application of electric pulses (8 pulses, duration 100 microseconds, frequency 8 Hz with amplitude adequate to cover the whole treated lesion with electric field necessary for reversible plasma membrane permeabilization), removal of electrodes.\n\nThe maximum duration of procedure is 90 minutes, after liver mobilization.', 'armGroupLabels': ['Electrochemotherapy treatment']}, {'name': 'Bleomycin PHC 15 e. (United States Pharmacopeia - USP)', 'type': 'DRUG', 'description': 'Intravenous in bolus administration of bleomycin (15 mg/m2)', 'armGroupLabels': ['Electrochemotherapy treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'University Medical Centre Ljubljana, Ljubljana, Slovenia', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'overallOfficials': [{'name': 'Mihajlo Djokic, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Centre Ljubljana, Ljubljana, Slovenia'}, {'name': 'Blaz Trotovsek, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Centre Ljubljana, Ljubljana, Slovenia'}, {'name': 'Gregor Sersa, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institute of Oncology Ljubljana, Slovenia'}, {'name': 'Borut Stabuc, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Medical Centre Ljubljana, Ljubljana, Slovenia'}, {'name': 'Dragoje Stanisavljevic, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Medical Centre Ljubljana, Ljubljana, Slovenia'}, {'name': 'Valentin Sojar, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Medical Centre Ljubljana, Ljubljana, Slovenia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masa Bosnjak', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institute of Oncology Ljubljana', 'class': 'OTHER'}, {'name': 'University of Ljubljana', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD, MPharm', 'investigatorFullName': 'Masa Bosnjak', 'investigatorAffiliation': 'University Medical Centre Ljubljana'}}}}