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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.