TheraSphere in Unresectable Hepatocellular Carcinoma (HCC) TS-103
Research type
Research Study
Full title
A Phase III Clinical Trial of Intra-arterial TheraSphere® in the Treatment of Patients with Unresectable Hepatocellular Carcinoma (HCC)
IRAS ID
143226
Contact name
Tim Meyer
Contact email
Sponsor organisation
Biocompatibles UK Ltd
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
CIV-12-10-008943, Eudamed number:
Duration of Study in the UK
4 years, 5 months, 1 days
Research summary
Patients with liver cancer, also called hepatocellular carcinoma, will be invited to take part in this study.
TheraSphere is a medical device approved in the United States for the treatment of hepatocellular carcinoma, and in Europe for the treatment of hepatic neoplasia. It consists of millions of microscopic glass spheres that are injected into the main artery in the liver to deliver radiation therapy directly to the tumor. Nexavar (sorafenib) is a drug approved in the United States and in Europe for the treatment of hepatocellular carcinoma.
The purpose of this research study is to examine whether adding treatment with TheraSphere before beginning the current standard treatment for liver cancer (sorafenib) is better than the current treatment alone. Better means slowing or stopping the growth of liver tumors without experiencing a significant increase in number or severity of side effects.
There will be two randomly selected treatment groups and results from each treatment group will be compared to find out which treatment option works better. All patients will receive standard-of-care sorafenib. They have an equal chance of receiving no additional therapy besides the standard of care sorafenib, or being treated with TheraSphere before the standard of care treatment with sorafenib is started.
The doses, duration of treatment and schedule of therapies that they will receive will depend on the Group where they are assigned. A number of procedures will be performed to check eligibility and follow up progress, including blood tests and imaging studies (CT scan or MRI). Participants will continue to take Sorafenib until they or the doctor decide to stop treatment, and will be asked to return to the study doctor every 8 weeks for a follow up evaluation.
About 390 patients will take part at up to 105 sites in the US,Canada, Asia and Europe.REC name
London - Hampstead Research Ethics Committee
REC reference
14/LO/2182
Date of REC Opinion
29 Dec 2014
REC opinion
Further Information Favourable Opinion