Status:
UNKNOWN
Electromagnetic Fields Versus Placebo For Child-Pugh A and B Patients With Advanced Hepatocellular Carcinoma
Lead Sponsor:
THERABIONIC INC.
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 radiofreque...
Detailed Description
Primary Objectives To compare the overall survival between subjects with advanced hepatocellular carcinoma treated either with a device emitting radiofrequencies modulated at specific frequencies or ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2024
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT04797884
Start Date
July 1 2023
End Date
October 30 2024
Last Update
June 28 2023
Active Locations (7)
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1
Tampa General Hospital, Tampa General Cancer Center
Tampa, Florida, United States, 33606
2
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States, 60611
3
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
4
Oregon Health & Science University, Knight Cancer Institute
Portland, Oregon, United States, 97239