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Sorafenib Tosylate in Treating Patients With Liver Cancer Who Have Undergone a Liver Transplant

2014-08-27 03:24:19 | BioPortfolio

Summary

RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sorafenib after liver transplant may be an effective treatment for liver cancer.

PURPOSE: This phase I trial is studying the side effects of sorafenib tosylate in treating patients with liver cancer who have undergone a liver transplant.

Description

OBJECTIVES:

Primary

- To establish the safety and toxicity profile of adjuvant sorafenib tosylate in patients with hepatocellular carcinoma who have undergone orthotopic liver transplantation.

Secondary

- To determine explant and allograft expression of VEGF, PDGFR, CD34 (microvessel density), and Ki67 (proliferation marker) in these patients.

OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 1-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Tissue samples from liver explant and post-transplantation core liver biopsies are analyzed for expression of VEGF, PDGFR, CD34, and Ki67 by IHC.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Study Design

Primary Purpose: Treatment

Conditions

Liver Cancer

Intervention

sorafenib tosylate, protein expression analysis, immunohistochemistry staining method, laboratory biomarker analysis, adjuvant therapy

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle
Washington
United States
98109-1024

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:24:19-0400

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Hepatology is the study of liver, gallbladder, biliary tree, and pancreas, and diseases associated with them. This includes viral hepatitis, alcohol damage, cirrhosis and cancer. As modern lifestyles change, with alcoholism and cancer becoming more promi...


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