Study Of Intrabucally Administered Electromagnetic Fields and Regorafenib

NCT04327700 | Terminated Phase 2 Results DMC FDA Drug FDA Device

• 3 other identifiers: IRB00064732WFBCCC 55319P30CA012197
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of this study is to gather efficacy data concerning the progression-free survival rate with electromagnetic fields plus Regorafenib when compared to historical data with Regorafenib alone as a second-line therapy in patients with advanced hepatocellular carcinoma who have received any first line systemic therapy either standard of care Sorafenib or Lenvatinib or any experimental therapy. Patients who have received any treatment that includes either electromagnetic fields or Regorafenib will be excluded.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  Progression-free survival (PFS) at 12 weeks after study enrollment. PFS assessment will be recorded in days and will represent the period starting at the date of enrollment and finishing at the later of the date of documentation of radiologic tumor progression, date of last follow-up on study treatment or death, whichever comes first. Patients who initiate post-study anti-tumor therapy prior to radiologic progression will be censored for PFS at that date. PFS is defined as at least a 20% increase in the sum of the longest diameters of target lesions compared to the smallest sum recorded (nadir), plus an absolute increase of at least 5 mm.

  12 weeks

Secondary Outcomes (5)

• Overall Survival

  12 weeks

• Percentage of Participants With Disease Control

  At 12 weeks

• Adverse Events by Body System

  Up to 30 days after study completion, up to 9 months

• Number of Participants With Grade 3+ Adverse Events - Comparison of Adverse Events (WFBCCC 55319 to RESORCE Historical Trial)

  Adverse events were collected during the course of treatment with a maximum of 9 months

• Change in Alpha-fetoprotein Levels

  6 months

Study Arms (1)

Regorafenib and TheraBionic

EXPERIMENTAL

TheraBionic is a device that consists of battery-driven radiofrequency electromagnetic field generator. The metal mouth spoon antenna is placed on the anterior part of the tongue during treatment. Regorafenib is a 40 mg tablet administered orally.

Device: TheraBionic; Drug: Regorafenib

Interventions

TheraBionic DEVICE

Amplitude-modulated electromagnetic fields will be self-administered and given continuously to patients in three courses of 60-minute treatments per day, administered in the morning, at noon and in the evening at the patient's home, with the exception of the first 60-minute treatment, which will be delivered at the research site. Each 4 week treatment period will be considered a cycle of treatment.

Also known as: Amplitude-modulated electromagnetic field device

Regorafenib and TheraBionic

Regorafenib DRUG

Patients will receive 160 mg regorafenib (four 40 mg tablets) orally once daily for the first 3 weeks of each 4-week cycle per approved prescribing information.

Also known as: Stivarga

Regorafenib and TheraBionic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy-proven hepatocellular carcinoma is locally advanced or metastatic. OR
• Patients without biopsy confirmation are also eligible if they meet the following:
• Radiologic diagnosis of hepatocellular carcinoma as per the American Association for the Study of Liver Diseases (AASLD) guidelines:
• liver cirrhosis AND
• a liver mass confirmed by blinded independent central review that shows arterial phase hyperenhancement on triphasic 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.
• Patient must have been treated with at least one standard systemic treatment modality for advanced hepatocellular carcinoma such as sorafenib, lenvatanib, atezolizumab plus bevacizumab, or another approved or experimental systemic therapy prior to study entry.
• Measurable disease according to RECIST version 1.1 and mRECIST for hepatocellular carcinoma.
• At least one target lesion should not have 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 version 1.1 and mRECIST for hepatocellular carcinoma.
• Patients with Child's Pugh A (at time of enrollment), with compensated cirrhosis, as defined by the parameters contained in the Child Pugh Calculator found in Appendix E.
• Performance status Eastern Cooperative Oncology Group (ECOG) 0-2
• Absence of medical or psychiatric contraindication which, in the opinion of the treating Investigator, would make the patient's participation in this trial inappropriate.
• Patient must not have curative treatment options, including surgery or radiofrequency ablation, available.
• Any extra-hepatic metastases, including treated central nervous system metastases but patients cannot have leptomeningeal disease.

You may not qualify if:

• Known leptomeningeal disease.
• Fibro lamellar hepatocellular carcinoma.
• Patients who had surgical resection of the disease and who do not have measurable disease.
• Patients with any of the following history within the 12 months prior to study drug administration: severe/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 diagnosed with another type of cancer (excluding basal cell carcinoma) whose cancer diagnosed previously is not in remission.
• Patients receiving calcium channel blockers and any agent blocking L-type or T-type Voltage Gated Calcium Channels, e.g. amlodipoine, nifedipine, ethosuximide, etc. are not allowed in the study unless their medical treatment is modified to exclude calcium channel blockers prior to enrollment.
• Patients allergic or intolerant to Sorafenib.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator
• THERABIONIC INC.: collaborator

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

regorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: Study Coordinator
• Organization: Wake Forest Baptist Comprehensive Cancer Center

ahumbert@advocatehealth.org

336-713-6912

Study Officials

• Ravi Paluri, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 31, 2020
• Study Start: January 26, 2021
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: March 5, 2026
• Results First Posted: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)