Trial · NCT04327700

Study Of Intrabucally Administered Electromagnetic Fields and Regorafenib

NCT04327700, Phase 2, Terminated, Wake Forest University Health Sciences; results first posted 2026-03-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study Of Intrabucally Administered Electromagnetic Fields and Regorafenib. Trials, record NCT04327700. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04327700

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study Of Intrabucally Administered Electromagnetic Fields and Regorafenib
NCT number: NCT04327700
Status: Terminated
Phases: Phase 2
Enrollment: 2 participants, actual
Lead sponsor: Wake Forest University Health Sciences
Conditions: Hepatocellular Carcinoma
Interventions: TheraBionic, Regorafenib
First posted: 2020-03-31
Last updated: 2026-03-05
Results first posted: 2026-03-05

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression-Free Survival	12 weeks	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.
Secondary	Overall Survival	12 weeks	Overall 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.
Secondary	Percentage of Participants With Disease Control	At 12 weeks	Disease 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.
Secondary	Adverse Events by Body System	Up to 30 days after study completion, up to 9 months	Type 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.
Secondary	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	Any 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.
Secondary	Change in Alpha-fetoprotein Levels	6 months	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.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-Free Survival	12 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Overall Survival	12 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage of Participants With Disease Control	At 12 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Adverse Events by Body System	Up to 30 days after study completion, up to 9 months		participants	NUMBER
SECONDARY	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		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in Alpha-fetoprotein Levels	6 months	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.

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Progression-Free Survival	Regorafenib and TheraBionic		2	Participants
Overall Survival	Regorafenib and TheraBionic		2	Participants
Percentage of Participants With Disease Control	Regorafenib and TheraBionic		2	Participants
Adverse Events by Body System	Regorafenib and TheraBionic	Endocrine disorders grade	1	participants
Adverse Events by Body System	Regorafenib and TheraBionic	Gastrointestinal disorders	1	participants
Adverse Events by Body System	Regorafenib and TheraBionic	Investigations (abnormal lab result no specified)	1	participants
Adverse Events by Body System	Regorafenib and TheraBionic	Metabolism and nutrition disorders	1	participants
Adverse Events by Body System	Regorafenib and TheraBionic	Nervous system disorders	1	participants
Adverse Events by Body System	Regorafenib and TheraBionic	Vascular disorders	1	participants
Number of Participants With Grade 3+ Adverse Events - Comparison of Adverse Events (WFBCCC 55319 to RESORCE Historical Trial)	Regorafenib and TheraBionic		1	Participants

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Regorafenib and TheraBionic	2
Overall Study	COMPLETED	Regorafenib and TheraBionic	2
Overall Study	NOT COMPLETED	Regorafenib and TheraBionic	0

Source ClinicalTrials.gov

Adverse events13

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Blood and lymphatic system disorders	Blood and lymphatic system disorders	Regorafenib and TheraBionic	1	2	2
other	Endocrine disorders	Endocrine disorders	Regorafenib and TheraBionic	1	2	2
other	Gastrointestinal disorders	Gastrointestinal disorders	Regorafenib and TheraBionic	2	2	6
other	General disorders and administration site conditions	General disorders	Regorafenib and TheraBionic	1	2	2
other	Infections and infestations	Infections and infestations	Regorafenib and TheraBionic	1	2	1
other	Investigations	Investigations	Regorafenib and TheraBionic	1	2	15
other	Metabolism and nutrition disorders	Metabolism and nutrition disorders	Regorafenib and TheraBionic	2	2	17
other	Musculoskeletal and connective tissue disorders	Musculoskeletal and connective tissue disorders	Regorafenib and TheraBionic	1	2	1
other	Nervous system disorders	Nervous system disorders	Regorafenib and TheraBionic	1	2	1
other	Renal and urinary disorders	Renal and urinary disorders	Regorafenib and TheraBionic	1	2	1

1 to 10 of 13Source ClinicalTrials.gov

See all 13 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Regorafenib and TheraBionic	1	2
Total, other adverse events	Regorafenib and TheraBionic	2	2
Total, serious adverse events	Regorafenib and TheraBionic	0	2

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P30CA012197	Cancer Center Support Grant	MESA, RUBEN A.	WAKE FOREST UNIVERSITY HEALTH SCIENCES	NATIONAL CANCER INSTITUTE	1985 to 2025

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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GET https://conductscience.org/api/trials/v1/NCT04327700/registered

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