# Randomized phase II study of TheraBionic in advanced hepatocellular carcinoma

> **NIH NIH R44** · THERABIONIC INC. · 2021 · $1,059,091

## Abstract

The average survival time of patients suffering from advanced HCC is less than six months, less than four-
months without treatment. Tumor resection is the first therapeutic approach when possible. However, the
majority of patients are not surgical candidates. Atezolizumab+bevacizumab is the most recent first-line
treatment approved by the FDA. Other systemic therapies in Phase III trials, including regorafenib, lenvatinib,
cabozantinib, and ramucirumab, show clinical efficacy. While these new therapies provide additional options,
incremental survival benefits are limited to 3-4 months and most new therapies can only be used in patients with
preserved liver function. Additional therapies for this disease are needed, especially for patients with advanced
disease who progress after first, second, or third line therapy and for those with severely impaired liver function.
TheraBionic Inc. has developed the TheraBionic P1, an amplitude modulated (AM) radiofrequency (RF)
electromagnetic field (EMF) emitting device for the systemic treatment of advanced hepatocellular carcinoma
with or without metastases in patients who have exhausted all curative treatment options. The TheraBionic P1
system consists of an RF EMF generator, coupled with an antenna (patient spoon), which is placed non-
surgically in the patient’s mouth. A carrier frequency (27.12 MHz), with AM at proprietary tumor-specific
frequencies, results in whole-body absorption. In preliminary studies, 14 out of 41 patients (34.1%) had stable
disease for more than 6 months. Median progression-free survival and overall survival were 4.4 and 6.7 months,
respectively. There were three partial and one near complete responses with treatment well tolerated. The
TheraBionic P1 has been allowed for compassionate use in the U.S. and has received FDA Breakthrough Device
Designation (BDD) as well as CE certification in Europe as a last line of treatment when all else has fails. The
objective of this SBIR Direct to Phase II proposal is to gather efficacy data concerning overall survival with AM
RF EMF in subjects who have failed or are intolerant to at least two previous systemic therapies, with the goal
of expanding indications to include use as a standard third line of treatment. Specific Aim 1: Clinical trial of
TheraBionic P1 AM RF EMF in advanced HCC patients. We will conduct a prospective, double-blind, two-arm
randomized controlled multi-site trial at Memorial Sloan-Kettering Cancer Center (Dr. Ghassan Abou-Alfa, lead
PI), Wake Forest Baptist Comprehensive Cancer Center (Dr. William Blackstock, co-PI), Lurie Comprehensive
Cancer Center of Northwestern University (Dr. Al B. Benson, III, MD co-I), and Mayo Clinic Cancer Center (Dr.
Tanios S. Bekaii-Saab, Co-I) with 162 subjects randomized 1:1 to each arm (treatment arm with AM RF EMF,
placebo arm with unmodulated RF EMF). Specific Aim 2: Primary and secondary objective analyses. The
primary objective is to estimate overall survival (OS). Secondary object...

## Key facts

- **NIH application ID:** 10254967
- **Project number:** 1R44CA256984-01A1
- **Recipient organization:** THERABIONIC INC.
- **Principal Investigator:** Valerie Pasche
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,059,091
- **Award type:** 1
- **Project period:** 2021-09-22 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10254967

## Citation

> US National Institutes of Health, RePORTER application 10254967, Randomized phase II study of TheraBionic in advanced hepatocellular carcinoma (1R44CA256984-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10254967. Licensed CC0.

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