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Study of SIR-Spheres Plus Sorafenib as 1st Line Treatment for Non-resectable Primary Hepatocellular Carcinoma (HCC)

NCT00712790 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2016-01-06

No results posted yet for this study

Summary

This Phase I/II trial will evaluate the safety and activity of chemo-radiotherapy comprising a regimen of Sorafenib chemotherapy plus SIR-Spheres yttrium-90 microspheres (chemo-radiotherapy, also known as "chemo-SIRT"), for first-line treatment of patients with primary hepatocellular carcinoma (HCC) in whom surgical resection is not feasible.

This study is designed as a prelude to a planned future randomised comparative study that will compare the efficacy of Sorafenib plus SIR-Spheres versus Sorafenib alone, in this patient population.

Conditions

Interventions

DRUG

Sorafenib

Tablet, 400mg orally, twice daily

RADIATION

SIR-Spheres

one time treatment and capped at 3.0 Gbq

Sponsors & Collaborators

  • National Medical Research Council (NMRC), Singapore

    collaborator OTHER_GOV

  • Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

    collaborator INDUSTRY

  • Sirtex Medical

    collaborator INDUSTRY

  • Singapore Clinical Research Institute

    lead OTHER

Principal Investigators

  • Pierce Chow, Phd · SGH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-06-30
Completion
2014-04-30

Countries

  • Burma
  • Malaysia
  • Singapore
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00712790 on ClinicalTrials.gov