Actively Recruiting
Amplitude-modulated Radiofrequency Electromagnetic Field Treatment for Advanced Hepatocellular Carcinoma (Immune-RF)
Led by Charite University, Berlin, Germany · Updated on 2025-02-12
36
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Combined double immune checkpoint inhibition and radiofrequency electromagnetic field treatment for patients with advanced hepatocellular carcinoma
CONDITIONS
Official Title
Amplitude-modulated Radiofrequency Electromagnetic Field Treatment for Advanced Hepatocellular Carcinoma (Immune-RF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Treatment with combined Anti-PD-L1 and Anti-CTLA-4 antibodies
- Written informed consent prior to any study procedure
- 18 years or older
- Histologically confirmed hepatocellular carcinoma (HCC)
- HCC not suitable for curative or locoregional therapies
- No prior systemic therapy for HCC
- Compensated liver function with Child-Pugh score 64 B7
- Eastern Cooperative Oncology Group (ECOG) performance status 64 2
- Measurable disease by mRECIST and RECIST v1.1 criteria
- Body weight greater than 30 kg
- Women of childbearing potential with negative pregnancy test and agreement for birth control
- Managed HBV and HCV infections according to institutional practice
You will not qualify if you...
- Arterioembolic event (stroke or myocardial infarction) within 3 months before randomization
- Severe or unstable angina, or symptomatic congestive heart failure (NYHA III/IV)
- Presence of cardiac pacemakers or implantable cardioverter defibrillators (ICD)
- Large metal implants in the treatment area
- Current coagulopathy or bleeding disorders
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Decompensated liver function with Child-Pugh score E7 B8
- Patients on a liver transplantation list
- Autoimmune disorders or organ transplantation requiring immunosuppressive therapy
- Uncontrolled autoimmune or inflammatory disorders
- Inability to lie supine (e.g., due to pain)
- Significantly altered mental status
- Pregnancy and breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Charité University Medicine Berlin
Berlin, Germany, 13353
Actively Recruiting
Research Team
P
Pirus Ghadjar, Prof. Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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