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Sponsors and Collaborators: |
Ministry of Health, Singapore National Medical Research Council (NMRC), Singapore Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma Sirtex Medical |
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Information provided by: | Ministry of Health, Singapore |
ClinicalTrials.gov Identifier: | NCT00712790 |
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.
Condition | Intervention | Phase |
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Hepatocellular Carcinoma |
Drug: Sorafenib Radiation: SIR-Spheres |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Study of SIR-Spheres Plus Sorafenib (Chemo-Radiotherapy) as First Line Treatment in Patients With Non-Resectable Primary Hepatocellular Carcinoma |
Estimated Enrollment: | 31 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Any of the following contraindications to angiography and selective visceral catheterization:
Contact: Pierce Chow, Phd | 65 6222 3322 | gsupc@singnet.com.sg |
Contact: Priscilla Li, MSc | 65 6325 7081 | priscilla@cteru.com.sg |
Singapore | |
Singapore General Hospital | Recruiting |
Singapore, Singapore, 169608 | |
Contact: Pierce Chow, Phd 65 6222 3322 gsupc@singnet.com.sg | |
Contact: Priscilla Li, Msc 65 6325 7081 priscilla@cteru.com.sg | |
Principal Investigator: Pierce Chow, Phd | |
Sub-Investigator: S B Tan | |
Sub-Investigator: Anthony Goh | |
Sub-Investigator: H K Lai | |
Sub-Investigator: K H Tay | |
Sub-Investigator: Richard Lo | |
National Cancer Centre | Not yet recruiting |
Singapore, Singapore, 169610 | |
Sub-Investigator: Donald Poon | |
Sub-Investigator: KC Soo |
Principal Investigator: | Pierce Chow, Phd | SGH |
Responsible Party: | Singapore General Hospital ( A/Prof Pierce Chow ) |
Study ID Numbers: | NMRC - AHCC05 |
Study First Received: | July 7, 2008 |
Last Updated: | July 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00712790 |
Health Authority: | Singapore: Health Sciences Authority |
First line treatment for Hepatocellular Carcinoma |
Liver Neoplasms Liver Diseases Digestive System Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Liver neoplasms |
Gastrointestinal Neoplasms Adenocarcinoma Sorafenib Hepatocellular carcinoma Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |