Clinical Trial DRUG TS-104
- A prospective randomized clinical trial on 90Yttrium trans-arterial radio-Embolization (TheraSphere®) vs. Sorafenib for the treatment of advanced Hepatocellular Carcinoma (HCC) with Portal Vein Thrombosis (PVT)
- Principal Investigator
- Laura Kulik
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG TS-104
- The purpose of this study is to see if TheraSphere (medical device that delivers therapy directly to the tumor) lengthens survival time and is safer than sorafenib (current standard treatment)for treating hepatocellular carcinoma (cancer in the liver)in participants with portal vein thrombosis (a clot in the major vein of the liver).
- TheraSphere (the study device)consists of millions of microscopic glass spheres that contain a radioactive material (yttrium-90)that are injected into the main artery in the liver to deliver radiation therapy directly to the tumor. The current standard of care for HCC is sorafenib. Sorafenib is in a class of medications called multikinase inhibitors. It works by slowing the spread of cancer cells and is taken by mouth. This study will compare the results of both treatments to see which works better.
Some of the eligibility criteria include:
- Participants must be 18 years of age or older.
- Participants must have advanced stage hepatocellular carcinoma (HCC) with portal vein thrombosis (PVC).
- Participants cannot have extrahepatic metastases (cancer that has spread outside of the liver).
- Description of Treatment
- There will be two groups in this study, Group A and Group B. Participants will be assigned by a computer program to one of these treatment groups. The participant or the doctor cannot choose the treatment group. Participants will have an equal chance (like flipping a coin) of being placed in Group A or B. Group A will receive sorafenib taken twice a day by mouth. Group B will receive Therasphere treatment, which is a treatment delivered directly to the liver. To do this, a catheter will be placed in the hepatic artery (major artery of the liver). TheraSphere will be injected through the catheter. The radiation emitted by TheraSphere is confined within the participant’s body and is relatively short acting. Participants in Group B will be sent home when the doctor determines they are ready to be released. These participants can receive up to 2 additional treatments spaced at least 28 days apart. Both Group A and B will stay on the study until disease progression or the doctor removes them. Both groups will not go past 24 weeks of treatment.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 25-Oct-16 02:03 PM
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