Electromagnetic Fields Versus Placebo For Child-Pugh A and B Patients With Advanced Hepatocellular Carcinoma
ARTEMIS
A Randomized Study of Intrabucally Administered Electromagnetic Fields Versus Placebo for Patients With Child-Pugh A or B With Advanced Hepatocellular Carcinoma
3 other identifiers
interventional
166
1 country
7
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 radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hepatocellular-carcinoma
Started Jul 2023
Shorter than P25 for phase_2 hepatocellular-carcinoma
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2021
CompletedFirst Posted
Study publicly available on registry
March 15, 2021
CompletedStudy Start
First participant enrolled
July 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2024
CompletedJune 28, 2023
June 1, 2023
1.3 years
March 10, 2021
June 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall Survival
Overall survival assessment will be recorded in days and will represent the period starting at the date of treatment initiation and finishing at the date of patient death. Living patients at the time of analysis will have the date of last contact (consultation visit or phone contact) used to define overall survival.
Baseline to 6 months
Quality of Life Survey
Patient-reported hepatobiliary-specific disease-related symptoms will be assessed by the 18-item FACT-Hepatobiliary (Hep) subscale every cycle for the first 6 cycles then every other cycle thereafter, at the end of treatment, and at every 3 months during follow-up.
Baseline to 6 months
Secondary Outcomes (7)
Progression-Free Survival
Up to 2 years
Proportion of Patients With Disease Control
At 4 months and 6 months and up to 2 years
Proportion of Participants That Are Progression Free
At 12 weeks, 4 months and 6 months and up to 2 years
Incidences of Adverse Events - CTCAE version 5.0
Up to 28 days after study treatment administration or until death
Changes in Alfa-Fetoprotein Levels
6 months
- +2 more secondary outcomes
Study Arms (2)
TheraBionic Arm - Active Arm
EXPERIMENTALFor subjects who are randomized to the active arm, the device will be programmed with hepatocellular carcinoma-specific modulation frequencies and will be activated for \>200 one-hour treatment sessions.
Placebo Arm
PLACEBO COMPARATORFor subjects randomized to the placebo arm, the device will not emit any hepatocellular carcinoma-specific modulation frequencies and will be activated for \>200 one-hour treatment sessions.
Interventions
Each treatment day consists of three courses of 60-minute treatments to be administered in the morning, at noon, and in the evening. Each 6-week treatment period will be considered a cycle of treatment. With the exception of the first 60-minute treatment, which will be delivered at one of the recruiting site, all other treatments will be self-administered at the patient's home.
Each treatment day consists of three courses of 60-minute treatments to be administered in the morning, at noon, and in the evening. Each 6-week treatment period will be considered a cycle of treatment. With the exception of the first 60-minute treatment, which will be delivered at the recruiting site, all other treatments will be self-administered at the patient's home.
Eligibility Criteria
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.
- +2 more criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- THERABIONIC INC.lead
- National Cancer Institute (NCI)collaborator
Study Sites (7)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Valerie K Pasche, MD
THERABIONIC INC.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2021
First Posted
March 15, 2021
Study Start
July 1, 2023
Primary Completion
October 30, 2024
Study Completion
October 30, 2024
Last Updated
June 28, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Within six months of data publication
The investigators of this project will make the non-proprietary results and accomplishments of the research plan available to the research community and to the public at large by the timely release and sharing of data. As a means of sharing knowledge, the investigators supported by this grant will seek to publish the original research in primary scientific journals. The investigators will also assert copyright in scientific and technical articles based on data produced under the grant where necessary. For each publication that results from the grant-supported research, we will include an acknowledgment of NIH grant support and follow guidelines regarding free access to published materials. Information on each publication resulting from work performed under the NIH grant supported project will be included in the annual and/or final progress report submitted to the NIH awarding office. Proprietary developments will be protected using intellectual property rights.