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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.
- To establish the safety and toxicity profile of adjuvant sorafenib tosylate in patients with hepatocellular carcinoma who have undergone orthotopic liver transplantation.
- 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.
Primary Purpose: Treatment
sorafenib tosylate, protein expression analysis, immunohistochemistry staining method, laboratory biomarker analysis, adjuvant therapy
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:24:19-0400
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