Electromagnetic Field Therapy for Liver Cancer
(ARTEMIS Trial)

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen byValerie K Pasche, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

Sponsor: THERABIONIC INC.

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Valerie K Pasche, MD

Principal Investigator

THERABIONIC INC.

Eligibility Criteria

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.

Inclusion Criteria

- Total Bilirubin ≤ 3.0mg/l.

-- Is 10-19 mm with non-peripheral portal venous washout AND an enhancing capsule

- Albumin ≥ 2.8 mg/l

See 14 more

Exclusion Criteria

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

Pregnant or breastfeeding women.

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

See 7 more

Treatment Details

Interventions

Placebo Device (Placebo)
Quality of Life Assessment (Other)
TheraBionic Device (Electromagnetic Field Therapy)

Trial OverviewThe 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.

Participant Groups

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.