Quality of Life Assessment for Liver Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Liver Neoplasms+2 More
Quality of Life Assessment - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing if electromagnetic fields can help people with cancer who have failed or are intolerant to at least two previous systemic therapies.

Eligible Conditions
  • Liver Neoplasms
  • Hepatocellular Cancer (HCC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Up to 2 years

6 months
Changes in Alfa-Fetoprotein Levels
Year 2
Proportion of Participants That Are Progression Free
Year 2
Proportion of Patients With Disease Control
Month 6
Quality of Life Survey - FACT Hepatobiliary
Baseline to 6 months
Overall Survival
Quality of Life Survey - EQ-5D-5L
Up to 2 years
Progression-Free Survival
Day 28
Number of Adverse Events

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

TheraBionic Arm - Active Arm
1 of 2
Placebo Arm
1 of 2

Experimental Treatment

Non-Treatment Group

166 Total Participants · 2 Treatment Groups

Primary Treatment: Quality of Life Assessment · Has Placebo Group · Phase 2

TheraBionic Arm - Active ArmExperimental Group · 2 Interventions: Quality of Life Assessment, TheraBionic Device · Intervention Types: Other, Device
Placebo ArmPlaceboComparator Group · 2 Interventions: Quality of Life Assessment, Placebo Device · Intervention Types: Other, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

TheraBionic, Inc.UNKNOWN
1 Previous Clinical Trials
25 Total Patients Enrolled
TherabionicsUNKNOWN
National Cancer Institute (NCI)NIH
12,993 Previous Clinical Trials
41,300,285 Total Patients Enrolled
175 Trials studying Liver Neoplasms
22,852 Patients Enrolled for Liver Neoplasms
Wake Forest University Health SciencesLead Sponsor
1,113 Previous Clinical Trials
1,129,603 Total Patients Enrolled
5 Trials studying Liver Neoplasms
173 Patients Enrolled for Liver Neoplasms
William Blackstock, MDPrincipal InvestigatorWake Forest University Health Sciences
4 Previous Clinical Trials
67 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have hepatocellular carcinoma that is locally advanced or metastatic or radiologically diagnosed as per the AASLD guidelines or is ≥ 20 mm with either non-peripheral portal venous washout or an enhancing capsule.
Patients with locally advanced or metastatic HCC who have not received treatment for HCC within the past 12 months and who have a Child-Pugh score of B8 or B9 at the time of enrollment are eligible for this study.
You have an albumin level of at least 2.8 mg/l.
You have a total bilirubin level of less than 3.0mg/l.
You are at least 2 weeks post-treatment with any anticancer treatment prior to initiation of protocol therapy.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 27th, 2021

Last Reviewed: November 14th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.