Intrabucally Administered Electromagnetic Fields Versus Placebo as Third-line Therapy For Patients With Advanced Hepatocellular Carcinoma

Inclusion Criteria

• •Biopsy-proven hepatocellular carcinoma that is locally advanced or metastatic
• •Patients must have measurable disease.
• •Failure or intolerance to prior treatments with at least two different approved or experimental systemic therapies including sorafenib, lenvatinib, regorafenib, cabozantinib, ramucirumab, nivolumab, nivolumab plus ipilumab, atezolizumab and bevacizumab, or any approved or experimental first line and/or second line therapy that did not include the TheraBionic device (defined as documented radiological progression according to the radiology charter). Randomization needs to be performed within 10 weeks after the last systemic treatment
• •Measurable disease according to mRECIST for hepatocellular carcinoma.
• •At least one target lesion should not have previously received any local therapy, such as surgery, radiation therapy, hepatic arterial embolization, TACE, hepatic arterial infusion, radio-frequency ablation, percutaneous ethanol injection or cryoablation, unless it has subsequently progressed by 20% or more according to mRECIST for hepatocellular carcinoma.
• •Patients with Child's Pugh A or B (at time of enrollment) as defined by the parameters contained in the Child Pugh Calculator.-Subjects with Child's Pugh score of B8-B9 may be included if they have: Albumin \> 2.8 mg/l AND Total Bilirubin \< 3.0mg/l, Performance status ECOG 0-2.
• •Patient must not have curative treatment options, including surgery or radiofrequency ablation, available as assessed by their physician.
• •Any extra-hepatic metastases, including treated CNS metastases but patients cannot have leptomeningeal disease.
• •At least 4 weeks must have elapsed since administration of any anti-cancer treatment.
• •Other anti-cancer treatments are not permitted during this study
• •Patients must be more than 18 years old and must be able to understand and sign an informed consent.
• •Patient must agree to be followed up according to the study protocol.