Trial Outcomes & Findings for Study Of Intrabucally Administered Electromagnetic Fields and Regorafenib (NCT NCT04327700)
NCT ID: NCT04327700
Last Updated: 2026-03-05
Results Overview
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.
TERMINATED
PHASE2
2 participants
12 weeks
2026-03-05
Participant Flow
Participant milestones
| Measure |
Regorafenib and TheraBionic
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.
TheraBionic: 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.
Regorafenib: 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.
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Overall Study
STARTED
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2
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Overall Study
COMPLETED
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2
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Of Intrabucally Administered Electromagnetic Fields and Regorafenib
Baseline characteristics by cohort
| Measure |
Regorafenib and TheraBionic
n=2 Participants
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.
TheraBionic: 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.
Regorafenib: 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.
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Age, Categorical
<=18 years
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0 Participants
n=41 Participants
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Age, Categorical
Between 18 and 65 years
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0 Participants
n=41 Participants
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Age, Categorical
>=65 years
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2 Participants
n=41 Participants
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Sex: Female, Male
Female
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0 Participants
n=41 Participants
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Sex: Female, Male
Male
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2 Participants
n=41 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=41 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=41 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=41 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=41 Participants
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Race (NIH/OMB)
White
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2 Participants
n=41 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=41 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=41 Participants
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Region of Enrollment
United States
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2 participants
n=41 Participants
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PRIMARY outcome
Timeframe: 12 weeksProgression-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.
Outcome measures
| Measure |
Regorafenib and TheraBionic
n=2 Participants
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.
TheraBionic: 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.
Regorafenib: 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.
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Progression-Free Survival
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2 Participants
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SECONDARY outcome
Timeframe: 12 weeksOverall Survival (OS) at 12 weeks. OS 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 last follow-up on study or death, whichever comes first.
Outcome measures
| Measure |
Regorafenib and TheraBionic
n=2 Participants
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.
TheraBionic: 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.
Regorafenib: 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.
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Overall Survival
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2 Participants
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SECONDARY outcome
Timeframe: At 12 weeksDisease control is defined as the percentage of participants alive and have documented response status of complete response, partial response or stable disease according to the modified RECIST (mRECIST) for hepatocellular carcinoma. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of longest diameters of target lesions, without evidence of disease progression. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.
Outcome measures
| Measure |
Regorafenib and TheraBionic
n=2 Participants
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.
TheraBionic: 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.
Regorafenib: 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.
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Percentage of Participants With Disease Control
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2 Participants
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SECONDARY outcome
Timeframe: Up to 30 days after study completion, up to 9 monthsType and incidence adverse events grade 2 or higher, graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Adverse events will be described for this study using counts/percents.
Outcome measures
| Measure |
Regorafenib and TheraBionic
n=2 Participants
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.
TheraBionic: 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.
Regorafenib: 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.
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Adverse Events by Body System
Endocrine disorders grade
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1 participants
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Adverse Events by Body System
Gastrointestinal disorders
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1 participants
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Adverse Events by Body System
Investigations (abnormal lab result no specified)
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1 participants
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Adverse Events by Body System
Metabolism and nutrition disorders
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1 participants
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Adverse Events by Body System
Nervous system disorders
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1 participants
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Adverse Events by Body System
Vascular disorders
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1 participants
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SECONDARY outcome
Timeframe: Adverse events were collected during the course of treatment with a maximum of 9 monthsAny grade 3+ adverse event graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Adverse events will be compared for the treatment group (WFBCCC 55319 study) and historical control (from the RESORCE trial), using the Fisher's exact test (two-sided) at level 0.05. These comparisons will be made to compare events of grade greater than or equal to 3 between each group.
Outcome measures
| Measure |
Regorafenib and TheraBionic
n=2 Participants
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.
TheraBionic: 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.
Regorafenib: 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.
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Number of Participants With Grade 3+ Adverse Events - Comparison of Adverse Events (WFBCCC 55319 to RESORCE Historical Trial)
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1 Participants
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SECONDARY outcome
Timeframe: 6 monthsPopulation: Only one study participant stayed on study to the six month point. Reporting values for a single patient would be reporting individualized data so this was not analyzed. The one participant did not allow analysis for this outcome measure for data to be collected.
Average alpha-fetoprotein level levels will be examined over time, and these changes in Alfa-fetoprotein rates after 6 months will be examined for each Response category (complete response/ partial response/ stable disease/ progressive disease) and tested using a 1-way ANOVA to see if the change in alpha-fetoprotein level differs by response category.
Outcome measures
Outcome data not reported
Adverse Events
Regorafenib and TheraBionic
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Regorafenib and TheraBionic
n=2 participants at risk
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.
TheraBionic: 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.
Regorafenib: 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.
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Blood and lymphatic system disorders
Blood and lymphatic system disorders
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50.0%
1/2 • Number of events 2 • Adverse events were collected during the course of treatment with a maximum of 9 months. All cause mortality was assessed beyond the end of treatment with the maximum being 3.3 years.
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Endocrine disorders
Endocrine disorders
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50.0%
1/2 • Number of events 2 • Adverse events were collected during the course of treatment with a maximum of 9 months. All cause mortality was assessed beyond the end of treatment with the maximum being 3.3 years.
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Gastrointestinal disorders
Gastrointestinal disorders
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100.0%
2/2 • Number of events 6 • Adverse events were collected during the course of treatment with a maximum of 9 months. All cause mortality was assessed beyond the end of treatment with the maximum being 3.3 years.
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General disorders
General disorders and administration site conditions
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50.0%
1/2 • Number of events 2 • Adverse events were collected during the course of treatment with a maximum of 9 months. All cause mortality was assessed beyond the end of treatment with the maximum being 3.3 years.
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Infections and infestations
Infections and infestations
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50.0%
1/2 • Number of events 1 • Adverse events were collected during the course of treatment with a maximum of 9 months. All cause mortality was assessed beyond the end of treatment with the maximum being 3.3 years.
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Investigations
Investigations
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50.0%
1/2 • Number of events 15 • Adverse events were collected during the course of treatment with a maximum of 9 months. All cause mortality was assessed beyond the end of treatment with the maximum being 3.3 years.
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Metabolism and nutrition disorders
Metabolism and nutrition disorders
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100.0%
2/2 • Number of events 17 • Adverse events were collected during the course of treatment with a maximum of 9 months. All cause mortality was assessed beyond the end of treatment with the maximum being 3.3 years.
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Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
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50.0%
1/2 • Number of events 1 • Adverse events were collected during the course of treatment with a maximum of 9 months. All cause mortality was assessed beyond the end of treatment with the maximum being 3.3 years.
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Nervous system disorders
Nervous system disorders
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50.0%
1/2 • Number of events 1 • Adverse events were collected during the course of treatment with a maximum of 9 months. All cause mortality was assessed beyond the end of treatment with the maximum being 3.3 years.
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Renal and urinary disorders
Renal and urinary disorders
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50.0%
1/2 • Number of events 1 • Adverse events were collected during the course of treatment with a maximum of 9 months. All cause mortality was assessed beyond the end of treatment with the maximum being 3.3 years.
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Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
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100.0%
2/2 • Number of events 2 • Adverse events were collected during the course of treatment with a maximum of 9 months. All cause mortality was assessed beyond the end of treatment with the maximum being 3.3 years.
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Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
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50.0%
1/2 • Number of events 2 • Adverse events were collected during the course of treatment with a maximum of 9 months. All cause mortality was assessed beyond the end of treatment with the maximum being 3.3 years.
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Vascular disorders
Vascular disorders
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50.0%
1/2 • Number of events 6 • Adverse events were collected during the course of treatment with a maximum of 9 months. All cause mortality was assessed beyond the end of treatment with the maximum being 3.3 years.
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Additional Information
Study Coordinator
Wake Forest Baptist Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place