NCT06821958 Amplitude-modulated Radiofrequency Electromagnetic Field Treatment for Advanced Hepatocellular Carcinoma (Immune-RF)
| NCT ID | NCT06821958 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Charite University, Berlin, Germany |
| Condition | Hepatocellular Carcinoma (HCC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2026-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2025-03-01 with a primary completion date of 2026-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Combined double immune checkpoint inhibition and radiofrequency electromagnetic field treatment for patients with advanced hepatocellular carcinoma
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06821958 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatocellular Carcinoma (HCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06821958 currently recruiting?
Yes, NCT06821958 is actively recruiting participants. Contact the research team at pirus.ghadjar@charite.de for enrollment information.
Where is the NCT06821958 trial being conducted?
This trial is being conducted at Berlin, Germany.
Who is sponsoring the NCT06821958 clinical trial?
NCT06821958 is sponsored by Charite University, Berlin, Germany. The trial plans to enroll 36 participants.
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