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Amplitude-Modulated Electromagnetic Fields and Regorafenib as Second-Line Therapy for the Treatment of Patients with Advanced Hepatocellular Carcinoma

Trial Status: Active

This phase II trial studies the effects of amplitude-modulated electromagnetic fields and regorafenib as second-line therapy for the treatment of patients with hepatocellular carcinoma that has spread to other places in the body (advanced), and who have received any first line systemic therapy, either standard of care sorafenib or lenvatinib, or any experimental therapy. Amplitude-modulated electromagnetic fields may interfere with the growth of tumor cells by directing radio waves at the tumor. Regorafenib interferes with the growth of tumor cells. Giving amplitude-modulated electromagnetic fields and regorafenib may kill more cancer cells.

Inclusion Criteria

  • Biopsy-proven HCC that is locally advanced or metastatic. Or
  • Patients without biopsy confirmation are also eligible if they meet the following: * Radiologic diagnosis of HCC 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 (BICR) that shows arterial phase hyperenhancement on triphasic computed tomography (CT) or magnetic resonance imaging (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
  • Patients must have been treated with at least one standard systemic treatment modality for advanced HCC such as sorafenib, lenvatinib, 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 HCC
  • 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 HCC
  • Patients with Child’s Pugh A (at time of enrollment), with compensated cirrhosis, as defined by the parameters contained in the Child Pugh calculator
  • 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 (CNS) 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 able to understand and sign an informed consent
  • Patient must agree to be followed up according to the study protocol

Exclusion Criteria

  • Known leptomeningeal disease
  • Fibro lamellar HCC
  • Patients who had surgical resection of the disease and who do not have measurable disease
  • Patients with any of the following history within the 12 months prior to study drug administration: severe/unstable angina, myocardial infarction, coronary artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, including transient ischemic attack, or pulmonary embolism
  • Pregnant or breastfeeding women
  • Patients diagnosed with another type of cancer (excluding basal cell carcinoma) whose cancer diagnosed previously is not in remission
  • Patients receiving calcium channel blockers and any agent blocking L-type or T-type voltage gated calcium channels, e.g. amlodipine, nifedipine, ethosuximide, etc. are not allowed in the study unless their medical treatment is modified to exclude calcium channel blockers prior to enrollment
  • Patients allergic or intolerant to sorafenib

North Carolina

Winston-Salem
Wake Forest University Health Sciences
Status: ACTIVE
Contact: Arthur William Blackstock
Phone: 336-713-3600

PRIMARY OBJECTIVE:

I. To estimate progression-free survival rates according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and modified RECIST (mRECIST) for hepatocellular carcinoma (HCC).

SECONDARY OBJECTIVES:

I. To obtain information concerning overall survival-defined as date of enrollment to date of death; progression-free survival at 4 months, 6- month survival rate, proportion of patients with disease control (complete or partial response or stable disease) according to RECIST 1.1 and modified RECIST (mRECIST) for HCC at 4 and 6 months, and time to radiologic progression.

II. To evaluate type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 5.0), timing, seriousness, and relatedness of adverse events and laboratory abnormalities.

III. To evaluate the effect on levels of alpha-fetoprotein.

OUTLINE:

Patients receive regorafenib orally (PO) once daily (QD) for 3 weeks. Patients also receive amplitude-modulated electromagnetic fields using the TheraBionic device three times daily (TID) over 60 minutes each. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days, and then every 2 months until 1 year after end of treatment visit.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Wake Forest University Health Sciences

Principal Investigator
Arthur William Blackstock

  • Primary ID WFBCCC 55319
  • Secondary IDs NCI-2020-08486, IRB00064732
  • Clinicaltrials.gov ID NCT04327700