Study of SIR-Spheres Plus Sorafenib as 1st Line Treatment for Non-resectable Primary Hepatocellular Carcinoma (HCC)
Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Singapore Clinical Research Institute
Collaborators:
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma National Medical Research Council (NMRC), Singapore Sirtex Medical