Treatment for advanced liver cancer using radiofrequency electromagnetic fields
Amplitude-modulated Radiofrequency Electromagnetic Field Treatment for Advanced Hepatocellular Carcinoma (Immune-RF)
This study is testing a new treatment that combines immune therapy with radiofrequency electromagnetic fields to see if it helps people with advanced liver cancer who can't have surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Berlin) |
| Trial ID | NCT06821958 on ClinicalTrials.gov |
What this trial studies
This study investigates the combined effect of double immune checkpoint inhibition and radiofrequency electromagnetic field treatment in patients with advanced hepatocellular carcinoma (HCC). Conducted at Charité University Medicine Berlin, the trial aims to assess the feasibility of this innovative approach, comparing outcomes with a control group receiving only immune checkpoint inhibitors. The study focuses on patients who are not candidates for curative therapies and have not received prior systemic treatment for HCC. The goal is to gather prospective data on the effectiveness and safety of this combined treatment strategy.
Who should consider this trial
Good fit: Ideal candidates include adults with histologically confirmed advanced hepatocellular carcinoma who are eligible for combined immune checkpoint inhibition and have not received prior systemic therapy.
Not a fit: Patients with curable HCC or those who have received prior systemic therapy for HCC may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced liver cancer who currently have limited treatment choices.
How similar studies have performed: While there is retrospective data suggesting effectiveness, this approach is novel and has not been extensively tested in prospective trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * 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 Exclusion criteria: * 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 * 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
Where this trial is running
Berlin
- Charité University Medicine Berlin — Berlin, Germany (Recruiting)
Study contacts
- Study coordinator: Pirus Ghadjar, Prof. Dr.
- Email: pirus.ghadjar@charite.de
- Phone: +49 30 450 527318
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.