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
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combined treatment approach for patients with advanced hepatocellular carcinoma (HCC), a type of liver cancer. This study aims to assess the feasibility of adding radiofrequency electromagnetic field treatment to the standard first-line palliative double immune checkpoint inhibition therapy. The trial compares these combined results with data from patients receiving only the immune checkpoint inhibitors, addressing a gap in prospective data for this combination in advanced HCC treatment. Participants will receive routine double immune checkpoint inhibition therapy, as used in the HIMALAYA phase III trial STRIDE arm, alongside radiofrequency electromagnetic field treatment delivered for 60 minutes twice weekly. The radiofrequency treatment uses a carrier frequency of 13.56 MHz and is provided using a specialized device available at Charité University Medicine Berlin. The study is non-randomized and open-label, focusing on this combined treatment regimen. During the trial, participants will be monitored regularly with assessments every 10 to 12 weeks to measure objective response rate until disease progression or for up to three years. Safety measures include monitoring acute and late toxicity over four years, alongside evaluations of quality of life, progression-free survival, overall survival, time to progression, and duration of response. These comprehensive evaluations aim to understand the treatment's impact and tolerability over the trial period.
CONDITIONS
Brief 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 \u2264 B7
- Eastern Cooperative Oncology Group (ECOG) performance status \u2264 2
- Measurable disease by mRECIST and RECIST v1.1 criteria
- Body weight over 30 kg
- Women of childbearing potential with negative pregnancy test and agreement for birth control if conception possible
- Managed HBV and HCV infection if present according to local practice
You will not qualify if you...
- Arterioembolic event such as 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 \u2265 B8
- Patients listed for liver transplantation
- Autoimmune disorders or organ transplantation history requiring immunosuppressive therapy
- Uncontrolled autoimmune or inflammatory disorders
- Inability to lie flat due to pain or other reasons
- Significantly altered mental status
- Pregnancy and breastfeeding
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or a maximum follow-up of 3 years
Participants receive routine double immune checkpoint inhibition combined with radiofrequency electromagnetic field treatment twice a week.
Twice weekly visits for radiofrequency electromagnetic field treatment
Duration - Up to 4 years of trial conduction
Participants are monitored for acute and late toxicity, quality of life, progression-free survival, overall survival, time to progression, and duration of response.
Assessments every 10 to 12 weeks until progression, then continued monitoring
Trial Site Locations
Total: 1 location
1
Charité University Medicine Berlin
Berlin, Germany, 13353
Actively Recruiting
Research Team
P
Pirus Ghadjar, Prof. Dr.
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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