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Sorafenib Tosylate and Yttrium Y 90 Glass Microspheres in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

Unresectable Hepatocellular Carcinoma Clinical Trial

Official title:
A Phase II Study of Sorafenib and Yttrium-90 Glass Microspheres for Advanced Hepatocellular Carcinoma, BCLC Stage C

Clinical Trial Summary

This phase II trial studies how well sorafenib tosylate and yttrium Y 90 glass microspheres work in treating patients with liver cancer that cannot be removed by surgery. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Yttrium Y 90 glass microspheres use glass beads to carry radiation directly to tumor cells without harming normal cells. Giving sorafenib tosylate with yttrium Y 90 glass microspheres may be an effective treatment for liver cancer.

Clinical Trial Description

PRIMARY OBJECTIVES: I. Median progression-free survival (PFS). SECONDARY OBJECTIVES: I. Overall survival (OS). II. Time to radiographic progression (TTRP). III. To evaluate the safety of the combination of sorafenib (sorafenib tosylate) and Yttrium-90; adverse events (National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [NCI-CTAE v 4.0]). OTHER OBJECTIVES: I. Predictive biomarkers of response to therapy and survival: will assess pre-treatment plasma level of insulin-like growth factor 1 (IGF-1) as above, and assess its predictive ability of time to progression (TTP) and OS. OUTLINE: Patients receive sorafenib tosylate orally (PO) twice daily (BID). After 4 weeks, patients receive yttrium Y 90 glass microspheres intra-arterially (IA). Courses of sorafenib tosylate repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months. ;

Study Design

Related Conditions & MeSH terms

  • Advanced Adult Hepatocellular Carcinoma
  • BCLC Stage C Hepatocellular Carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular
  • Recurrent Adult Hepatocellular Carcinoma
  • Stage III Hepatocellular Carcinoma AJCC v7
  • Stage IIIA Hepatocellular Carcinoma AJCC v7
  • Stage IIIB Hepatocellular Carcinoma AJCC v7
  • Stage IIIC Hepatocellular Carcinoma AJCC v7
  • Stage IV Hepatocellular Carcinoma AJCC v7
  • Stage IVA Hepatocellular Carcinoma AJCC v7
  • Stage IVB Hepatocellular Carcinoma AJCC v7
  • Unresectable Hepatocellular Carcinoma
Clinical Trial Details
NCT number NCT01900002
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Completed
Phase Phase 2
Start date September 13, 2013
Completion date December 10, 2020
View Details
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