Electromagnetic Fields Versus Placebo For Child-Pugh A and B Patients With Advanced Hepatocellular Carcinoma

Launched by THERABIONIC INC. · Mar 12, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at how effective a special device, which emits electromagnetic fields, is for treating patients with advanced liver cancer, known as hepatocellular carcinoma (HCC), compared to a device that doesn't emit these fields. The main goals of the study are to see if this treatment can help patients live longer and improve their quality of life. The trial is open to adults aged 18 and older who have a specific type of liver cancer and meet certain health criteria. Participants can include those who have had previous treatments that didn't work or those who haven't yet received treatment.

If you decide to join the trial, you will receive either the active treatment or a placebo (a device that doesn't do anything) and will be monitored closely throughout the study. There are some requirements to participate, such as having a certain level of liver function and not having other serious health issues. If you're interested, it's important to discuss this with your doctor to see if you meet the eligibility criteria and to understand what being part of the study would involve.

Gender

ALL

Eligibility 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 participants: 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.
• • Child-Pugh B participants are not required to have received any prior treatment.
• • Measurable disease according to RECIST v 1.1.
• • 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 greater than or equal to 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 according to the study protocol.