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

NCT01887717 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-04-21

Study results available
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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.

Conditions

Interventions

DEVICE

TheraSphere®

Intrahepatic treatment of advanced hepatocellular carcinoma

DRUG

Sorafenib

Standard of care therapy for treatment of advanced hepatocellular carcinoma

Sponsors & Collaborators

  • Biocompatibles UK Ltd

    collaborator INDUSTRY
  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Vincenzo Mazzaferro, MD · Istituto Tumori Nazionale, Milan, Italy

  • Riad Salem, MD · Northwestern University Chicago Illinois

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-27
Primary Completion
2017-05-23
Completion
2017-05-23

Countries

  • United States
  • Belgium
  • France
  • Italy
  • Spain
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01887717 on ClinicalTrials.gov