What side effects are associated with this type of intervention?

Common treatments for liver cancer, such as transarterial chemoembolization (TACE), radiofrequency ablation (RFA), microwave ablation (MWA), and radiation therapy (RT), have various side effects. TACE can cause gastroduodenal ulcers, elevated liver enzymes, and bilirubin levels. RFA and MWA may lead to local pain, fever, and changes in liver function. RT, including stereotactic body radiation therapy (SBRT), can result in gastrointestinal toxicity, liver damage, and fatigue. Devices emitting modulated radiofrequencies, similar to other ablative therapies, may also cause localized pain and changes in liver function, but specific side effects are still under investigation.

What prior FDA approvals exist?

The FDA has approved several treatments for liver cancer, including systemic therapies like sorafenib (Nexavar) and lenvatinib (Lenvima), which are tyrosine kinase inhibitors. Additionally, immune checkpoint inhibitors such as pembrolizumab (Keytruda) and nivolumab (Opdivo) have been approved for advanced hepatocellular carcinoma. Local treatments like transarterial chemoembolization (TACE) and radiofrequency ablation (RFA) are also commonly used. While the investigational device emitting modulated radiofrequencies is a novel approach, it shares the goal of enhancing therapeutic effects by more effectively targeting cancer cells, similar to how RFA and TACE aim to localize treatment to the tumor site.

What other types of research exist?

Promising novel alternatives for liver cancer treatment in 2024 include: 1) Transarterial chemoembolization (TACE) combined with sorafenib, which has shown efficacy in multiple trials. 2) Yttrium-90 (90Y) radioembolization, a targeted radiation therapy that delivers high doses of radiation directly to the tumor. 3) Drug-eluting bead TACE, which uses beads to deliver chemotherapy directly to the tumor, reducing systemic side effects. 4) Investigational gastric electrical stimulation devices that enhance slow wave regularity and amplitudes, potentially improving treatment outcomes. These alternatives offer targeted approaches that may improve therapeutic effects and patient outcomes.

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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

Must not have

Fibrolamellar HCC or combined hepatocellular-cholangiocarcinoma (cHCC-CC).

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Summary

This trial is testing a device that uses radio waves to treat advanced liver cancer. It aims to see if adjusting the radio waves' patterns makes a difference in survival and quality of life for patients with specific liver function levels. This method has shown benefits in local tumor control and survival rates.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

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My liver cancer diagnosis follows AASLD guidelines.

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My liver cancer has spread or is in an advanced stage.

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I am 18 or older and can understand and sign a consent form.

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I have tried at least two treatments for my condition without success or could not tolerate them.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My liver cancer is either fibrolamellar HCC or combined HCC-CC.

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I haven't had major heart or stroke issues in the last year.

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I agree to follow the study's check-up schedule.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival

Quality of Life Survey

Secondary study objectives

Changes in Alfa-Fetoprotein Levels

Frequency of Adverse Events - PRO-CTCAE

Functional Assessment of Cancer Therapy-General (FACT-G) Item GP5

+4 more

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

~570

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for liver cancer include surgical resection, radiofrequency ablation (RFA), transarterial chemoembolization (TACE), and radiation therapy. Surgical resection involves removing the tumor and surrounding tissue, which is effective for localized cancer. RFA uses heat generated by radio waves to destroy cancer cells, while TACE delivers chemotherapy directly to the liver tumor through the blood vessels, blocking the blood supply and trapping the drug in the tumor. Radiation therapy uses high-energy rays to kill cancer cells. The investigational device emitting modulated radiofrequencies aims to enhance therapeutic effects by more effectively targeting cancer cells, potentially improving outcomes for patients with advanced hepatocellular carcinoma. This matters for liver cancer patients as it offers a non-invasive treatment option that could increase survival rates and quality of life.