Study Of Intrabucally Administered Electromagnetic Fields and Regorafenib

NCT ID: NCT04327700

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-26
• Study Completion Date: 2024-05-31

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.

Detailed Description

Primary Objective: To estimate progression-free survival rates.

Secondary Objectives

• To obtain information concerning the feasibility of administration of the proposed treatment, including patient participation in trials using the proposed treatment.
• To evaluate safety and tolerability in this patient population.
• To evaluate the effect on levels of alpha-fetoprotein.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

TheraBionic

Intervention Type: 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.

Regorafenib

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DRUG

Other Intervention Names

Amplitude-modulated electromagnetic field device; Stivarga

Eligibility Criteria

Inclusion Criteria

• 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.
• At least 2 weeks must have elapsed since administration of any anti-cancer treatment.
• Other anti-cancer treatments are not permitted during this study, including alternative medicine and herbal therapies.
• Patients must be 18+ years old and must be able to understand and sign an informed consent.
• Patient must agree to be followed up according to the study protocol.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

THERABIONIC INC.

OTHER

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ravi Paluri, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

WFBCCC 55319

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00064732

Identifier Type: -

Identifier Source: org_study_id