A Phase III Clinical Trial of Intra-arterial TheraSphere® in the Treatment of Patients With Unresectable Hepatocellular Carcinoma (HCC)
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Unresectable Hepatocellular Carcinoma
Both
Unresectable Hepatocellular Carcinoma
Trial Information
A Phase III Clinical Trial of Intra-arterial TheraSphere® in the Treatment of Patients With Unresectable Hepatocellular Carcinoma (HCC)
Inclusion Criteria:
- Unresectable advanced HCC not amenable to curative procedures, with planned
standard-of-care sorafenib therapy
Exclusion Criteria:
- Main portal vein thrombosis
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Outcome Time Frame:
From time of randomization up to 36 months
Safety Issue:
No
Principal Investigator
Riad Salem, MD, MBA
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dept of Radiology Northwestern University
Authority:
United States: Food and Drug Administration
Study ID:
TS-103
NCT ID:
NCT01556490
Start Date:
March 2012
Completion Date:
October 2016
Related Keywords:
- Unresectable Hepatocellular Carcinoma
- Carcinoma
- Carcinoma, Hepatocellular
Name | Location |
|---|---|
| Northwestern Memorial Hospital | Chicago, Illinois 60611 |
| Banner Good Samaritan Medical Center | Phoenix, Arizona 85006 |
| University of Washington | Seattle, Washington 98195 |
| Thomas Jefferson University | Philadelphia, Pennsylvania 19107-6541 |
| University of Louisville | Louisville, Kentucky 40202 |
| H Lee Moffitt Cancer Center | Tampa, Florida 33612 |
| Karmanos Cancer Institute | Detroit, Michigan 48201 |
| Indiana University School of Medicine | Indianapolis, Indiana 46204 |
| University of Virginia Health System | Charlottesville, Virginia 22903 |
| Legacy Meridian Park Medical Center | Tualatin, Oregon 97062 |
