NCT01887717

Efficacy Evaluation of TheraSphere to Treat Inoperable Liver Cancer With Blockage of the Portal Vein

A Prospective Randomized Clinical Trial on 90Yttrium Trans-arterial Radio-Embolization (TheraSphere®) vs. Standard of Care (Sorafenib) for the Treatment of Advanced Hepatocellular Carcinoma (HCC) With Portal Vein Thrombosis (PVT)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a two-arm, open-label, prospective, multi-center, randomized, active-controlled clinical trial to assess efficacy and safety of TheraSphere in comparison to standard of care therapy (sorafenib) in the treatment of participants with inoperable liver cancer and blockage of the portal vein.

Detailed description

The objective of this Phase III, prospective randomized trial is to determine whether TheraSphere provides a meaningful benefit in survival in comparison with the standard of care (sorafenib) in participants with good hepatic function and advanced hepatocellular carcinoma (HCC) associated with portal vein thrombosis (PVT). This is an open-label prospective, multi-center, randomized, controlled clinical trial that will evaluate the use of TheraSphere compared to standard-of-care sorafenib alone.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DEVICE	TheraSphere®	Intrahepatic treatment of advanced hepatocellular carcinoma
DRUG	Sorafenib	Standard of care therapy for treatment of advanced hepatocellular carcinoma

Timeline

• Start date: 2014-02-27
• Primary completion: 2017-05-23
• Completion: 2017-05-23
• First posted: 2013-06-27
• Last updated: 2021-04-21
• Results posted: 2019-10-29

Locations

19 sites across 6 countries: United States, Belgium, France, Italy, Spain, United Kingdom