A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere (Yttrium-90 Glass Microspheres): A HDE Treatment Use Protocol
- Provide supervised access to treatment with yttrium Y 90 glass microspheres
(TheraSphere®) to eligible patients with primary cancer to the liver and who are not
surgical resection candidates.
- Evaluate patient experience and toxicities associated with TheraSphere® treatment.
- Enter treatment experience into a liver database.
- Determine the tumor response rates in patients receiving this treatment.
OUTLINE: This is a humanitarian device exemption use study.
Patients receive yttrium Y 90 glass microspheres (TheraSphere®) via percutaneous hepatic
arterial infusion. Patients may be retreated between 30-90 days after the initial infusion.
After completion of study therapy, patients are followed for 30 days and then annually
thereafter for up to 2 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Access to treatment
24 months after last treatment
Yi-Jen Chen, MD, PhD
City of Hope Medical Center
United States: Institutional Review Board
|City of Hope Medical Center||Duarte, California 91010|