Amplitude-modulated Radiofrequency Electromagnetic Field Treatment for Advanced Hepatocellular Carcinoma (Immune-RF)

Recruiting now · Not applicable

Conditions studied: Hepatocellular Carcinoma (HCC)

In brief

Combined double immune checkpoint inhibition and radiofrequency electromagnetic field treatment for patients with advanced hepatocellular carcinoma

Key facts

Study ID

NCT06821958

Run by

Charite University, Berlin, Germany

People needed

36

Starts

2025-03-01

Expected to finish

2029-02-28

Last updated by the study team

2025-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Charité University Medicine Berlin — Berlin, Germany (enrolling)

Full record on ClinicalTrials.gov

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