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

• Status: Recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The primary goal of this study is to gather efficacy data concerning overall survival with electromagnetic fields when compared to a placebo amplitude-modulated radiofrequency electromagnetic field device in subjects who have failed or are intolerant to at least two previous systemic therapies.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI); Therabionics

Criteria

Inclusion Criteria:

Biopsy-proven HCC that is locally advanced or metastatic OR

• Patients without biopsy confirmation are also eligible if they meet one of the following criteria:

1. Radiologic diagnosis of HCC as per the AASLD guidelines OR

2. Liver cirrhosis AND a liver mass that shows arterial phase hyperenhancement on triphasic computed tomography (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

• For Child-Pugh A and B7 patients: treatment failure (defined as documented radiological progression) and/or intolerance to at least two prior treatments with approved or experimental systemic therapies including atezolizumab plus bevacizumab, sorafenib, lenvatinib, regorafenib, cabozantinib, ramucirumab, nivolumab, nivolumab plus ipilimumab, pembrolizumab or any other approved or experimental first line and/or second line therapy.

• For patients who are Child-Pugh B8 and B9 at the time of diagnosis of locally advanced or metastatic HCC: treatment failure (defined as documented radiological progression) and/or intolerance to one immunotherapy treatment, e.g., nivolumab, atezolizumab, etc. Patients with a previously lower Child-Pugh score (A-B7) who received at least two prior lines of therapy prior to progressing to B8 or B9 disease also are eligible for the study.

• Measurable disease according to RECIST v 1.1 and mRECIST for HCC.

• At least one target lesion that has not 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 v 1.1 and mRECIST for HCC.

• Patients with Child-Pugh A or B (at time of enrollment) as defined by the parameters contained in the Child-Pugh Calculator. Subjects with Child-Pugh score of B8-B9 may be included if they have:

• Albumin ≥ 2.8 mg/l AND

• Total Bilirubin ≤ 3.0mg/l.

• ECOG performance status of 0-2.

• At least 2 weeks must have elapsed since administration of any anticancer treatment prior to initiation of protocol therapy.

• Patients must be ≥ 18 years old and must be able to understand and sign an informed consent.

Female patients of childbearing potential and their partners and male patients must agree to use adequate contraception during the period of study treatment.

Exclusion Criteria:

• Known leptomeningeal disease. (Previously treated, asymptomatic central nervous system (CNS) metastases are eligible).

• Fibrolamellar HCC or combined hepatocellular-cholangiocarcinoma (cHCC-CC).

• Prior treatment with the TheraBionic Device.

• Patients with any of the following within the 12 months prior to registration:

uncontrolled/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 with another active malignancy within the past one year except for treated cervical cancer in situ, treated in situ carcinoma of the bladder or treated non-melanoma carcinoma of the skin, low-risk prostate cancer not requiring active treatment, treated T1/T2 glottic cancer, treated stage 0 or stage I breast cancer not requiring adjuvant therapy or treated non-invasive bladder cancer.

• Patients receiving calcium channel blockers and any agent blocking L-type of T-type Voltage Gated Calcium Channels, e.g., amlodipine, nifedipine, ethosuximide, ascorbic acid (vitamin C), etc. unless their medical treatment is modified to exclude calcium channel blockers prior to enrollment.

• Patients with curative treatment options available, including surgery or radiofrequency ablation, as assessed by their physician.

• Patients receiving other anticancer treatments.

• Patients that do not agree to be followed up according to the study protocol.