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

Status unconfirmed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Hepatocellular Carcinoma

In brief

The primary goals of this study are to compare overall survival and quality of life in subjects with Child-Pugh A or B advanced hepatocellular carcinoma when treated with a device emitting radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies.

Key facts

Study ID

NCT04797884

Run by

THERABIONIC INC.

People needed

166

Starts

2023-07-01

Expected to finish

2024-10-30

Last updated by the study team

2023-06-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Radiologic diagnosis of HCC as per the AASLD guidelines OR
• 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.

You may not qualify if…

• 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.

Where it is running

• Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States (enrolling)
• Robert H. Lurie Comprehensive Cancer Center of Northwestern University — Chicago, Illinois, United States
• Tampa General Hospital, Tampa General Cancer Center — Tampa, Florida, United States
• Thomas Jefferson University Hospital, Sidney Kimmel Cancer Center — Philadelphia, Pennsylvania, United States
• DHR Health Advanced Care Center, DHR Oncology Institute — Edinburg, Texas, United States
• University of Texas Health Science Center, Mays Cancer Center — San Antonio, Texas, United States
• Oregon Health & Science University, Knight Cancer Institute — Portland, Oregon, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.