NCT04327700

Study Of Intrabucally Administered Electromagnetic Fields and Regorafenib

A Phase II Study Of Intrabucally Administered Electromagnetic Fields and Regorafenib as Second-line Therapy For Patients With Advanced Hepatocellular Carcinoma.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.
DRUG	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.

Timeline

• Start date: 2021-01-26
• Primary completion: 2024-05-31
• Completion: 2024-05-31
• First posted: 2020-03-31
• Last updated: 2026-03-05
• Results posted: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study