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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
Open (Enrolling)
Both
Unresectable Hepatocellular Carcinoma

Thank you

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 HospitalChicago, Illinois  60611
Banner Good Samaritan Medical CenterPhoenix, Arizona  85006
University of WashingtonSeattle, Washington  98195
Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541
University of LouisvilleLouisville, Kentucky  40202
H Lee Moffitt Cancer CenterTampa, Florida  33612
Karmanos Cancer InstituteDetroit, Michigan  48201
Indiana University School of MedicineIndianapolis, Indiana  46204
University of Virginia Health SystemCharlottesville, Virginia  22903
Legacy Meridian Park Medical CenterTualatin, Oregon  97062