TheraBionic Device for Carcinoma, Hepatocellular

1
Effectiveness
2
Safety
Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL
Carcinoma, Hepatocellular+2 More
TheraBionic Device - Device
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma, Hepatocellular

Study Summary

This study is evaluating whether electromagnetic fields may help treat cancer.

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Eligible Conditions

  • Carcinoma, Hepatocellular
  • Liver Neoplasms
  • Hepatocellular Cancer (HCC)

Treatment Effectiveness

Study Objectives

This trial is evaluating whether TheraBionic Device will improve 2 primary outcomes and 6 secondary outcomes in patients with Carcinoma, Hepatocellular. Measurement will happen over the course of Up to 28 days after study treatment administration or until death.

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 Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Placebo Arm
TheraBionic Arm - Active Arm
Placebo group

This trial requires 166 total participants across 2 different treatment groups

This trial involves 2 different treatments. TheraBionic Device is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

TheraBionic Arm - Active ArmFor subjects who are randomized to the active arm, the device will be programmed with hepatocellular carcinoma-specific modulation frequencies and will be activated for >200 one-hour treatment sessions.
Placebo ArmFor subjects randomized to the placebo arm, the device will not emit any hepatocellular carcinoma-specific modulation frequencies and will be activated for >200 one-hour treatment sessions.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2 years for reporting.

Closest Location

Robert H. Lurie Comprehensive Cancer Center of Northwestern University - Chicago, IL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 2 prior treatments for Carcinoma, Hepatocellular or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Biopsy-proven HCC that is locally advanced or metastatic OR Radiologic diagnosis of HCC as per the AASLD guidelines OR 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
For Child-Pugh A and B7 patients: treatment failure (defined as documented radiological progression) and/or intolerance to at least two prior treatments with approved or experimental systemic therapies including atezolizumab plus bevacizumab, sorafenib, lenvatinib, regorafenib, cabozantinib, ramucirumab, nivolumab, nivolumab plus ipilimumab, pembrolizumab or any other approved or experimental first line and/or second line therapy.
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. show original
Measurable disease according to RECIST v 1.1 and mRECIST for HCC.
At least one target lesion that has not 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 v 1.1 and mRECIST for HCC.
You have an albumin level of at least 2.8 mg/l. show original
You have a total bilirubin level of less than 3.0mg/l. show original
ECOG performance status of 0-2.
You are at least 2 weeks post-treatment with any anticancer treatment prior to initiation of protocol therapy. show original
Patients must be ≥ 18 years old and must be able to understand and sign an informed consent.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has therabionic device proven to be more effective than a placebo?

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Ultrasonic thermotherapy is more effective for HCC than for PNL. Thermotherapy with the therabionic device seems to be more effective than thermotherapy with sham device.

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What is carcinoma, hepatocellular?

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Carcinoma, hepatocellular most commonly affects HBV infected subjects mainly because of their tendency to over drinking or using unsafe practices. Early diagnosis is important to decrease the mortality rates.

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How many people get carcinoma, hepatocellular a year in the United States?

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The number of people who get carcinoma, hepatocellular at the time they are diagnosed is less than the number of those who die of the disease. Those with carcinoma, hepatocellular, live longer than those who die of the disease, so the survival rate would be underestimated if only those who are diagnosed with carcinoma, hepatocellular, and die at the time of death are counted. Copyright © 2015 John Wiley & Sons, Ltd.

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What are the signs of carcinoma, hepatocellular?

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Hepatocellular carcinoma (HCC) and cholangiocarcinoma (CC) are extremely rare for the U.S. population. The signs for metastatic spread in these malignancies are often nondominant, and the time delay inherent in the use of CT or MR imaging to search for these lesions may affect the clinical outcome of these patients.

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What are common treatments for carcinoma, hepatocellular?

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Treatments for hepatocellular carcinoma are similar to those for early stage colon cancer. Chemotherapy is often given as a first-line treatment, followed by surgery. There is a trend towards increased survival rate after the introduction of more targeted therapies. However, more evidence supporting the use of these newer drugs to improve outcomes will be needed.

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Can carcinoma, hepatocellular be cured?

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Despite all the advancements made in the treatment of primary cirrhosis, treatment of the hepatocellular cancer is still problematic at present and there are no curative treatments.

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What causes carcinoma, hepatocellular?

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Liver is the most common site for lesions that are thought to be cancers. A number of infectious agents, including viruses, bacteria and parasites, can contribute to cancer in the liver. Many drugs have been shown to cause carcinogenesis in various organs, including the liver. Chemoprevention with non-steroidal anti-inflammatory drugs may prevent colorectal cancer in individuals who smoke. Hepatitis B virus infection increases the risk of developing liver cancer.

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What does therabionic device usually treat?

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A high percentage of all ablation sites (76%), and a majority of sites (76%) that should be targeted for cryo-ablation (78%) were not covered by the therabionic device during the first treatment. When the device was treated during the second or third procedures the percentage of targeted sites covered was significantly higher (93% and 97% respectively). The percentage of unnecessary treatment sites (23% at first ablation) that were treated during the third procedure and unnecessary ablation sites (30%) treated during the second procedure was similar to a historical comparative data. The therabionic device covered more sites but treated fewer sites, when compared to cryo-ablation.

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What are the chances of developing carcinoma, hepatocellular?

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  1. The majority of the patients diagnosed with chronic liver disease will develop a carcinoma with some risk still remaining to be clarified and a better understanding of the pathogenesis of carcinoma development in such cases will be useful for the prevention of malignancies.
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How serious can carcinoma, hepatocellular be?

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Surgical treatments at our unit have been improved thanks to major changes in equipment and surgical technique; thanks to the use of multimodal surgery, the operative death rate has been reduced. These improvements give the opportunity to refine the treatment strategy of hepatocellular carcinoma so as to optimize the therapeutic strategy and minimize the survival times.

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What is the latest research for carcinoma, hepatocellular?

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Most studies on hepatocarcinoma have only focused on either one-time or multiple-time cancer occurrence without any focus on prognostic factors. On the other hand, most clinical trials on HCC have limitations in the patient number or enrollment process such as non-randomized or prospective analysis, inclusion of low-risk population, and so on. Therefore, the number of studies and clinical trials are not enough to reveal the actual prognostic effect and therapeutic strategy.

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What is the survival rate for carcinoma, hepatocellular?

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The prognosis of advanced HCC improves with survival from primary HCC. In the United States, median survival is approximately 18 months, which for patients treated medically is better than 3 months for patients treated surgically. Because the survival rate is better with medical treatment, primary treatment is often surgical. Liver transplantation can be considered and is often used in the United States.

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