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

Prior treatment

• 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
• Large metal implants in the treatment area
• Patients on a liver transplantation list

Other illness

• Cardiac pacemakers / ICD
• Current evidence of coagulopathy or bleeding diathesis
• Patients with autoimmune disorders or history of organ transplantation who require immunosuppressive therapy
• Uncontrolled autoimmune or inflammatory disorders

Other

• Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
• Decompensated liver function as defined by Child Pugh ≥ B8
• Patient not able for supine positioning (e.g. due to pain)
• Significantly altered mental status
• Pregnancy and breastfeeding

• 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