Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-01-05 @ 6:31 PM
Study NCT ID:
NCT06821958
Status:
RECRUITING
Last Update Posted:
2025-02-12
First Post:
2024-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Amplitude-modulated Radiofrequency Electromagnetic Field Treatment for Advanced Hepatocellular Carcinoma (Immune-RF)
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2029-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2024-12-21', 'studyFirstSubmitQcDate': '2025-02-11', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': 'Every 10-12 weeks until progression or a maximum follow-up of 3 years', 'description': 'Objective response rate'}], 'secondaryOutcomes': [{'measure': 'Acute and late toxicity', 'timeFrame': 'During 4 years of trial conduction', 'description': 'CTCAE version 5'}, {'measure': 'Quality of life (QoL)', 'timeFrame': 'During 4 years of trial conduction', 'description': 'European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30'}, {'measure': 'Quality of life (QoL)', 'timeFrame': 'During 4 years of trial conduction', 'description': 'European Organisation for Research and Treatment of Cancer (EORTC) QLQ-HCC18'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'During 4 years of trial conduction', 'description': 'Progression-free survival'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'During 4 years of trial conduction', 'description': 'Overall survival'}, {'measure': 'Time to progression (TTP)', 'timeFrame': 'During 4 years of trial conduction', 'description': 'Time to progression'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'During 4 years of trial conduction', 'description': 'Duration of response'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma (HCC)']}, 'descriptionModule': {'briefSummary': 'Combined double immune checkpoint inhibition and radiofrequency electromagnetic field treatment for patients with advanced hepatocellular carcinoma', 'detailedDescription': 'Charité University Medicine Berlin is currently the only German University Hospital with an available capacitive radiofrequency electromagnetic field treatment device. While there is retrospective data available regarding the assumed effectiveness and low toxicity profile of radiofrequency electromagnetic field treatment for various solid tumors including liver cancer, there is no prospective data available on the combined effect of first-line palliative double immune checkpoint inhibition and radiofrequency electromagnetic field treatment for patients with advanced hepatocellular carcinoma. The investigators aim to conduct a feasibility trial and plan to compare the results with data of a prospective trial with a comparable patient population who received double immune checkpoint inhibition alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treatment with combined Anti-PD-L1 and Anti-CTLA-4 antibodies\n* Written informed consent prior to any study procedure\n* 18 years or older\n* Histologically confirmed HCC\n* HCC not amenable to curative (including resection or ablation) or locoregional (including TACE) therapies\n* No prior systemic therapy for HCC\n* Compensated liver function, as defined by a Child-Pugh score ≤ B7\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Measurable disease by Response Criteria in Solid Tumors (mRECIST and RECIST v1.1) criteria\n* Body weight of \\> 30 kg\n* Women of childbearing potential with negative pregnancy test and agreement for adequate birth control if conception is possible\n* If present HBV and HCV managed according to the local institutional practice\n\nExclusion criteria:\n\n* Arterioembolic event including a stroke or myocardial infarction within 3 months prior to randomization Severe / unstable angina, or symptomatic congestive heart failure as defined by NYHA III/IV\n* Cardiac pacemakers / ICD\n* Large metal implants in the treatment area\n* Current evidence of coagulopathy or bleeding diathesis\n* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC\n* Decompensated liver function as defined by Child Pugh ≥ B8\n* Patients on a liver transplantation list\n* Patients with autoimmune disorders or history of organ transplantation who require immunosuppressive therapy\n* Uncontrolled autoimmune or inflammatory disorders\n* Patient not able for supine positioning (e.g. due to pain)\n* Significantly altered mental status\n* Pregnancy and breastfeeding'}, 'identificationModule': {'nctId': 'NCT06821958', 'briefTitle': 'Amplitude-modulated Radiofrequency Electromagnetic Field Treatment for Advanced Hepatocellular Carcinoma (Immune-RF)', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Amplitude-modulated Radiofrequency Electromagnetic Field Treatment for Advanced Hepatocellular Carcinoma (Immune-RF)', 'orgStudyIdInfo': {'id': 'Immune-RF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Routine double immune checkpoint inhibition (HIMALAYA phase III trail, STRIDE-arm) combined with radiofrequency electromagnetic field treatment for 60 minutes twice a week', 'interventionNames': ['Device: Radiofrequency electromagnetic field treatment']}], 'interventions': [{'name': 'Radiofrequency electromagnetic field treatment', 'type': 'DEVICE', 'description': 'Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Yvonne Saewe', 'role': 'CONTACT', 'email': 'yvonne.saewe@charite.de', 'phone': '+49 30 450 527318'}, {'name': 'Pirus Ghadjar, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Raphael Mohr, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Charité University Medicine Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Pirus Ghadjar, Prof. Dr.', 'role': 'CONTACT', 'email': 'pirus.ghadjar@charite.de', 'phone': '+49 30 450 527318'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Pirus Ghadjar', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}