RecruitingNot ApplicableNCT06821958

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

Sponsor

Charite University, Berlin, Germany

Enrollment

36 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Treatment with combined Anti-PD-L1 and Anti-CTLA-4 antibodies
Written informed consent prior to any study procedure
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

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

DEVICERadiofrequency electromagnetic field treatment

Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz

Charité University Medicine Berlin

Berlin, Germany

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NCT06821958