RECRUITING

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

Conditions

Hepatocellular Carcinoma Child-Pugh A and B

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized Study of Intrabucally Administered Electromagnetic Fields Versus Placebo for Patients With Child-Pugh A or B With Advanced Hepatocellular Carcinoma

Quick Facts

Study Start:2023-07

Study Completion:2024-10-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04797884

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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.

Inclusion Criteria

Exclusion Criteria

* 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.

* 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.

Contacts and Locations

Study Contact

Valerie K Pasche, MD

CONTACT

3129610168

valerie.pasche@therabionic.com

Boris C Pasche, MD, PhD

CONTACT

3122864703

boris.pasche@therabionic.com

Principal Investigator

Valerie K Pasche, MD

PRINCIPAL_INVESTIGATOR

THERABIONIC INC.

Study Locations (Sites)

Tampa General Hospital, Tampa General Cancer Center

Tampa, Florida, 33606

United States

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois, 60611

United States

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157

United States

Oregon Health & Science University, Knight Cancer Institute

Portland, Oregon, 97239

United States

Thomas Jefferson University Hospital, Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, 19107

United States

DHR Health Advanced Care Center, DHR Oncology Institute

Edinburg, Texas, 78539

United States

University of Texas Health Science Center, Mays Cancer Center

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: THERABIONIC INC.

Valerie K Pasche, MD, PRINCIPAL_INVESTIGATOR, THERABIONIC INC.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07

Study Completion Date2024-10-30

Study Record Updates

Study Start Date2023-07

Study Completion Date2024-10-30

Terms related to this study

Keywords Provided by Researchers

Child-Pugh A and B

Additional Relevant MeSH Terms

Hepatocellular Carcinoma