Hepatocellular Carcinoma (HCC)NCT06821958
Amplitude-modulated Radiofrequency Electromagnetic Field Treatment for Advanced Hepatocellular Carcinoma (Immune-RF)
A study testing Radiofrequency electromagnetic field treatment in people with Hepatocellular Carcinoma (HCC), run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Combined double immune checkpoint inhibition and radiofrequency electromagnetic field treatment for patients with advanced hepatocellular carcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Radiofrequency electromagnetic field treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2025to 28 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 HCC
- HCC not amenable to curative (including resection or ablation) or locoregional (including TACE) therapies
- No prior systemic therapy for HCC
Show all 12Show fewer
- Compensated liver function, as defined by a Child-Pugh score ≤ B7
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Measurable disease by Response Criteria in Solid Tumors (mRECIST and RECIST v1.1) criteria
- Body weight of > 30 kg
- Women of childbearing potential with negative pregnancy test and agreement for adequate birth control if conception is possible
- If present HBV and HCV managed according to the local institutional practice
Who cannot join
- 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
- Cardiac pacemakers / ICD
- Large metal implants in the treatment area
- Current evidence of coagulopathy or bleeding diathesis
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Decompensated liver function as defined by Child Pugh ≥ B8
Show all 12Show fewer
- Patients on a liver transplantation list
- Patients with autoimmune disorders or history of organ transplantation who require immunosuppressive therapy
- Uncontrolled autoimmune or inflammatory disorders
- Patient not able for supine positioning (e.g. due to pain)
- Significantly altered mental status
- Pregnancy and breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Charité University Medicine Berlin
Berlin, 13353
Yvonne Saewe, +49 30 450 527318, yvonne.saewe@charite.de
Pirus Ghadjar, Prof. Dr.
About this study
Combined double immune checkpoint inhibition and radiofrequency electromagnetic field treatment for patients with advanced hepatocellular carcinoma
Read the detailed description
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.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- Radiofrequency electromagnetic field treatment
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency electromagnetic field treatmentDevice
Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Routine double immune checkpoint inhibition (HIMALAYA phase III trail, STRIDE-arm) combined with radiofrequency electromagnetic field treatment for 60 minutes twice a week Receives: Device: Radiofrequency electromagnetic field treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Objective response rate
Measured: Every 10-12 weeks until progression or a maximum follow-up of 3 years
Secondary outcomes (7)
Acute and late toxicity
CTCAE version 5
Measured: During 4 years of trial conduction
Quality of life (QoL)
European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30
Measured: During 4 years of trial conduction
Quality of life (QoL)
European Organisation for Research and Treatment of Cancer (EORTC) QLQ-HCC18
Measured: During 4 years of trial conduction
Progression-free survival (PFS)
Progression-free survival
Measured: During 4 years of trial conduction
Overall survival (OS)
Overall survival
Measured: During 4 years of trial conduction
Time to progression (TTP)
Time to progression
Measured: During 4 years of trial conduction
Duration of response (DOR)
Duration of response
Measured: During 4 years of trial conduction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion15 Jun 2026 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pirus Ghadjar, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821958
- Sponsor's protocol ID
- Immune-RF
- Status last verified
- Feb 2025
- First submitted
- 21 Dec 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amplitude-modulated Radiofrequency Electromagnetic Field Treatment for Advanced Hepatocellular Carcinoma (Immune-RF)
- ClinicalTrials.gov ID
- NCT06821958
- Acronym / sponsor ID
- Immune-RF
- Conditions
- Hepatocellular Carcinoma (HCC)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Combined double immune checkpoint inhibition and radiofrequency electromagnetic field treatment for patients with advanced hepatocellular carcinoma
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Radiofrequency electromagnetic field treatmentRoutine double immune checkpoint inhibition (HIMALAYA phase III trail, STRIDE-arm) combined with radiofrequency electromagnetic field treatment for 60 minutes twice a week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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 HCC
- HCC not amenable to curative (including resection or ablation) or locoregional (including TACE) therapies
Key exclusion criteria (12 listed)
- 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
- Cardiac pacemakers / ICD
- Large metal implants in the treatment area
- Current evidence of coagulopathy or bleeding diathesis
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency electromagnetic field treatmentRadiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz | Device | Experimental |
Primary outcome
Objective response rate (ORR)
Time frame: Every 10-12 weeks until progression or a maximum follow-up of 3 years
Objective response rate
7 secondary outcomes
Acute and late toxicity
Time frame: During 4 years of trial conduction
Quality of life (QoL)
Time frame: During 4 years of trial conduction
Quality of life (QoL)
Time frame: During 4 years of trial conduction
Progression-free survival (PFS)
Time frame: During 4 years of trial conduction
Overall survival (OS)
Time frame: During 4 years of trial conduction
Time to progression (TTP)
Time frame: During 4 years of trial conduction
Duration of response (DOR)
Time frame: During 4 years of trial conduction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Hepatocellular Carcinoma (HCC)
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency electromagnetic field treatment in people with Hepatocellular Carcinoma (HCC), run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pirus Ghadjar, Prof. Dr. (+49 30 450 527318, pirus.ghadjar@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Every 10-12 weeks until progression or a maximum follow-up of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.