Last updated on January 2017

Safety Study of Regorafenib and SIR-Spheres Microspheres Radioembolization in Patients With Refractory Metastatic Colorectal Cancer With Liver Metastases


Brief description of study

The purpose of this study is to determine the safety of regorafenib, an antiangiogenic drug, when combined with radioembolization using SIR-Spheres® microspheres in the treatment of colorectal cancer (CRC) that has spread to the liver.

Detailed Study Description

Recent targeted therapies and treatment strategies have shown promise in colorectal cancer; however, elimination of disease remains a challenge once spread to the liver. Radioembolization using SIR-Spheres® microspheres (SIR-Spheres) to treat liver-only or liver-dominant metastatic colorectal cancer (mCRC) has been successful in this refractory setting. In this open-label study we will compare the safety of two treatment cohorts in which radioembolization will be administered using the device SIR-Spheres microspheres (90Y resin microspheres) in combination with regorafenib to patients with mCRC with liver metastases. The two treatment cohorts will be evaluated for safety, overall response rate (ORR), progression-free survival (PFS), and overall survival (OS).

Clinical Study Identifier: NCT02195011

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Sarah Cannon Research Institute

Florida Cancer Specialists - North
St. Petersburg, FL United States
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Sarah Cannon Research Institute

Research Medical Center
Kansas City, MO United States
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Sarah Cannon Research Institute

Tennessee Oncology PLLC
Nashville, TN United States
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