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Placebo
Electromagnetic Field Therapy for Liver Cancer (ARTEMIS Trial)
Phase 2 & 3
Recruiting
Led By William Blackstock, MD
Research Sponsored by THERABIONIC INC.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status of 0-2.
- Radiologic diagnosis of HCC as per the AASLD guidelines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
ARTEMIS Trial Summary
This trial is testing if electromagnetic fields can help people with cancer who have failed or are intolerant to at least two previous systemic therapies.
Who is the study for?
This trial is for adults with advanced liver cancer (Child-Pugh A or B hepatocellular carcinoma) who have measurable disease and haven't had certain local therapies on target lesions. Child-Pugh B patients don't need prior treatment, but Child-Pugh A must have tried at least two systemic therapies without success. Participants should be in fair health (ECOG 0-2), not pregnant, agree to contraception use, and not be on calcium channel blockers unless they switch medications.Check my eligibility
What is being tested?
The study tests a TheraBionic device emitting specific radiofrequencies against a placebo device with unmodulated frequencies. The main focus is to see if there's an improvement in survival time and life quality for those with advanced liver cancer using the TheraBionic device compared to the placebo.See study design
What are the potential side effects?
Since this trial involves non-invasive devices that emit radiofrequencies rather than drugs, traditional side effects like nausea or fatigue are unlikely. However, potential side effects aren't detailed here; participants will be monitored for any adverse reactions.
ARTEMIS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My liver cancer diagnosis follows AASLD guidelines.
Select...
My liver cancer has spread or is in an advanced stage.
Select...
I am 18 or older and can understand and sign a consent form.
Select...
I have tried at least two treatments for my condition without success or could not tolerate them.
ARTEMIS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival
Quality of Life Survey
Secondary outcome measures
Changes in Alfa-Fetoprotein Levels
Frequency of Adverse Events - PRO-CTCAE
Functional Assessment of Cancer Therapy-General (FACT-G) Item GP5
+4 moreARTEMIS Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TheraBionic Arm - Active ArmExperimental Treatment2 Interventions
For 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.
Group II: Placebo ArmPlacebo Group2 Interventions
For 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Quality of Life Assessment
2009
Completed Phase 2
~340
Find a Location
Who is running the clinical trial?
THERABIONIC INC.Lead Sponsor
1 Previous Clinical Trials
25 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,688 Total Patients Enrolled
104 Trials studying Liver Cancer
26,668 Patients Enrolled for Liver Cancer
Wake Forest University Health SciencesLead Sponsor
1,242 Previous Clinical Trials
1,004,101 Total Patients Enrolled
4 Trials studying Liver Cancer
208 Patients Enrolled for Liver Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have liver cirrhosis and a liver mass that appears brighter on specific scans.My liver cancer is either fibrolamellar HCC or combined HCC-CC.I haven't had major heart or stroke issues in the last year.It has been over 2 weeks since my last cancer treatment.I am eligible without a biopsy if I meet certain criteria.I agree to use effective birth control during the study.My liver function is moderately impaired, but not severely.My doctor says I can be treated with surgery or radiofrequency ablation for a cure.I am not taking calcium channel blockers, or I can stop them before joining.You have previously received treatment using the TheraBionic Device.I agree to follow the study's check-up schedule.I can take care of myself and am up and about more than half of my waking hours.My liver cancer diagnosis follows AASLD guidelines.I have a moderate level of liver damage and haven't had prior treatments.My liver cancer has spread or is in an advanced stage.I have a tumor that hasn't been treated locally, or it grew by 20% after such treatment.I am 18 or older and can understand and sign a consent form.I haven't had any active cancer in the past year, except for certain treated early-stage or non-invasive cancers.I have had brain or spinal cord metastases but am not currently showing symptoms.I have tried at least two treatments for my condition without success or could not tolerate them.You are currently undergoing other treatments for cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Arm
- Group 2: TheraBionic Arm - Active Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people currently signing up to participate in this research?
"The study, which was originally posted on November 1st, 2022 is still recruiting participants according to the information available on clinicaltrials.gov. The last update to the posting was on October 27th, 2022."
Answered by AI
How does Quality of Life Assessment impact patients long-term?
"Quality of Life Assessment is considered to be a 2 in terms of safety. This is due to it being a Phase 2 trial, where there is data supporting its safety but none for efficacy."
Answered by AI
How many places is this research project active?
"There are 8 total clinical trial sites that are currently running this study. A few examples of these locations include DHR Health Advanced Care Center, DHR Oncology Institute in Edinburg, University of Texas Health Science Center, Mays Cancer Center in San Antonio, and Oregon Health & Science University, Knight Cancer Institute in Portland."
Answered by AI
What is the desired outcome of this experiment?
"This upcoming clinical trial seeks to study Overall Survival rates over a six-month period. Additionally, Quality of Life Survey - FACT Hepatobiliary and Changes in Alfa-Fetoprotein Levels will be observed as secondary outcome measures. Lastly, the Proportion of Patients With Disease Control will also be monitored throughout the course of the trial."
Answered by AI
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