Study Of Intrabucally Administered Electromagnetic Fields and Regorafenib

Inclusion Criteria

• •Biopsy-proven hepatocellular carcinoma is locally advanced or metastatic. OR
• •Radiologic diagnosis of hepatocellular carcinoma as per the American Association for the Study of Liver Diseases (AASLD) guidelines:
• •liver cirrhosis AND
• •a liver mass confirmed by blinded independent central review that shows arterial phase hyperenhancement on triphasic CT or MRI, AND EITHER:
• •Is ≥20 mm with either non-peripheral portal washout or an enhancing capsule
• •OR is 10-19 mm with non-peripheral portal venous washout AND an enhancing capsule.
• •Patient must have been treated with at least one standard systemic treatment modality for advanced hepatocellular carcinoma such as sorafenib, lenvatanib, atezolizumab plus bevacizumab, or another approved or experimental systemic therapy prior to study entry.
• •Measurable disease according to RECIST version 1.1 and 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, transarterial chemoembolization (TACE), hepatic arterial infusion, radio-frequency ablation, percutaneous ethanol injection or cryoablation, unless it has subsequently progressed by 20% or more according to RECIST version 1.1 and mRECIST for hepatocellular carcinoma.
• •Patients with Child's Pugh A (at time of enrollment), with compensated cirrhosis, as defined by the parameters contained in the Child Pugh Calculator found in Appendix E.
• •Performance status Eastern Cooperative Oncology Group (ECOG) 0-2
• •Absence of medical or psychiatric contraindication which, in the opinion of the treating Investigator, would make the patient's participation in this trial inappropriate.
• •Patient must not have curative treatment options, including surgery or radiofrequency ablation, available.
• •Any extra-hepatic metastases, including treated central nervous system metastases but patients cannot have leptomeningeal disease.
• •At least 2 weeks must have elapsed since administration of any anti-cancer treatment.
• •Other anti-cancer treatments are not permitted during this study, including alternative medicine and herbal therapies.
• •Patients must be 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.