A Humanitarian Device Exemption Treatment Protocol of Therasphere for the Treatment of Unresectable Hepatocellular Carcinoma
Surgical resection of the affected portion of the liver offers the best chance for
disease-free survival in patients with hepatoma (HCC). Unfortunately, most hepatoma
patients present with disease that is not amenable to resection (multifocal disease) or have
other medical contraindications to surgery (limited hepatic reserve related to advanced
cirrhosis or chronic hepatitis). Fewer than 15%1 of hepatoma patients are suitable surgical
The objective of treatment with TheraSphere is to selectively administer a potentially
lethal dose of radioactive material to neoplastic tissue in the liver of patients with HCC.
Regional therapies for HCC may have several advantages over systemically administered
treatments. Irradiating a cancer prior to treatment with regional chemotherapy may be more
effective than either therapeutic modality alone. TheraSphere may also be of value as a
'bridging' treatment for HCC patients awaiting a donor organ for liver transplantation.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response to Treatment
Diagnostic imaging studies for assessment of tumor response will be performed according to usual standard of care as established by the referring oncologist. The principal clinician will be able to get a preliminary evaluation of tumor response in patients who return for subsequent treatment, as part of the imaging studies required for repeat safety screening of patients.
Through 24 months post-treatment
Susan Littman, MD
Thomas Jefferson University
United States: Institutional Review Board
|Thomas Jefferson University||Philadelphia, Pennsylvania 19107-6541|