NCT00503867

SIR-Spheres® for the Treatment of Unresectable Hepatocellular Carcinoma

A Pilot Study of Yttrium-90 Microspheres (SIR-Spheres®) Therapy for the Treatment of Unresectable Hepatocellular Carcinoma

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Sirtex Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to determine the safety and toxicity of treatment with SIR-Spheres® in patients with unresectable primary liver cancer or hepatocellular carcinoma (HCC). Other purposes of this study include assessment of the effect of treatment on overall survival, the length of time it takes for the disease to worsen, if and how the treatment affects the patient's quality of life, and if and how the cancer responds to the treatment.

Detailed description

This study is a multi-institutional, non-randomized pilot study that aims to assess the safety and toxicity of hepatic arterial radioembolization using SIR-Spheres yttrium-90 microspheres (SIR-Spheres microspheres) in the treatment of patients with unresectable primary hepatocellular carcinoma (HCC). The study aims to recruit 40 patients over a period of 24 months.

Conditions

• Carcinoma, Hepatocellular
• Hepatoma

Interventions

Type	Name	Description
DEVICE	SIR-Spheres microspheres	SIR-Spheres Yttrium-90 microspheres

Timeline

• Start date: 2007-07-18
• Primary completion: 2010-03-09
• Completion: 2010-03-09
• First posted: 2007-07-19
• Last updated: 2020-12-10
• Results posted: 2020-12-10

Locations

4 sites across 1 country: United States