Comparing electromagnetic fields and placebo for patients with advanced liver cancer
A Randomized Study of Intrabucally Administered Electromagnetic Fields Versus Placebo for Patients With Child-Pugh A or B With Advanced Hepatocellular Carcinoma
This study is testing whether a device that uses radio waves can help people with advanced liver cancer live longer and feel better compared to a fake device.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 166 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Therabionic INC. Academic / other |
| Drugs / interventions | atezolizumab, bevacizumab, ramucirumab, nivolumab, ipilimumab, pembrolizumab, lenvatinib, cabozantinib, radiation |
| Locations | 7 sites (Tampa, Florida and 6 other locations) |
| Trial ID | NCT04797884 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a device that emits modulated radiofrequencies compared to a placebo device in patients with advanced hepatocellular carcinoma classified as Child-Pugh A or B. The primary objectives include assessing overall survival and quality of life, while secondary objectives focus on progression-free survival, safety, tolerability, and changes in alpha-fetoprotein levels. Participants will be monitored for disease-related symptoms and treatment side effects to determine the potential benefits of the intervention.
Who should consider this trial
Good fit: Ideal candidates include patients with biopsy-proven or radiologically diagnosed advanced hepatocellular carcinoma who have Child-Pugh A or B liver function.
Not a fit: Patients with Child-Pugh C liver function or those who have not previously failed systemic therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new non-invasive treatment option that improves survival and quality of life for patients with advanced liver cancer.
How similar studies have performed: While the use of electromagnetic fields in cancer treatment is an emerging area, similar studies have shown promise, but this specific approach remains novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
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:
1. Radiologic diagnosis of HCC as per the AASLD guidelines OR
2. 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.
* Patients must be greater than or equal to 18 years old and must be able to understand and sign an informed consent.
* Female patients of childbearing potential and their partners and male patients must agree to use adequate contraception during the period of study treatment.
Exclusion Criteria:
* 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.
Where this trial is running
Tampa, Florida and 6 other locations
- Tampa General Hospital, Tampa General Cancer Center — Tampa, Florida, United States (Not_yet_recruiting)
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University — Chicago, Illinois, United States (Not_yet_recruiting)
- Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States (Recruiting)
- Oregon Health & Science University, Knight Cancer Institute — Portland, Oregon, United States (Not_yet_recruiting)
- Thomas Jefferson University Hospital, Sidney Kimmel Cancer Center — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
- DHR Health Advanced Care Center, DHR Oncology Institute — Edinburg, Texas, United States (Not_yet_recruiting)
- University of Texas Health Science Center, Mays Cancer Center — San Antonio, Texas, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Valerie K Pasche, MD — Therabionic INC.
- Study coordinator: Valerie K Pasche, MD
- Email: valerie.pasche@therabionic.com
- Phone: 3129610168
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.