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Phase II Trial of Sorafenib in Combination With Capecitabine for the Treatment of Patients With Measurable Hepatocellular Carcinoma

2014-08-27 03:17:16 | BioPortfolio

Summary

This research study will evaluate Sorafenib (Nexavar®) and Capecitabine (Xeloda®) to see the following:

- how effective this combination of study drugs will be in treating HCC

- how long subjects respond to these study drugs

- what types of side effects can be expected, and

- how severe the side effects are

All subjects in this study will receive:

- Sorafenib twice a day by mouth

- Capecitabine twice a day by mouth

Treatment will be given in a 28-day treatment cycle.

Subjects will take sorafenib every day of the cycle. Subjects will take capecitabine on days 1-7 and 15-21 of the cycle

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Hepatocellular Carcinoma

Intervention

Sorafenib, Capecitabine

Location

University of New Mexico Cancer Center
Albuquerque
New Mexico
United States
87106

Status

Recruiting

Source

New Mexico Cancer Care Alliance

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:16-0400

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PubMed Articles [3358 Associated PubMed Articles listed on BioPortfolio]

Downregulation of Raf-1 kinase inhibitory protein as a sorafenib resistance mechanism in hepatocellular carcinoma cell lines.

Although sorafenib enhances overall survival, sorafenib resistance has been reported to be a significant limiting factor for improved prognosis in patients with hepatocellular carcinoma (HCC). Therefo...

The excellent antitumor effect of apatinib alone as second-line therapy in a patient with sorafenib-refractory hepatocellular carcinoma: A case report.

Hepatocellular carcinoma (HCC) is a highly invasive cancer associated with high mortality rates. Although sorafenib is currently recommended as standard treatment for advanced HCC, its treatment effic...

Efficacy of annexin A3 blockade in sensitizing hepatocellular carcinoma to sorafenib and regorafenib.

Advanced hepatocellular carcinoma (HCC) is a lethal malignancy with limited treatment options. Sorafenib is the only FDA approved first-line targeted drug for advanced HCC, but its effect on patients'...

Cost-Effectiveness of Sorafenib Monotherapy and Selected Combination Therapy with Sorafenib in Patients with Advanced Hepatocellular Carcinoma.

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Impact of pre-sarcopenia in sorafenib treatment for advanced hepatocellular carcinoma.

The present study aimed to investigate the impact of pre-sarcopenia on the prognosis of patients with advanced hepatocellular carcinoma (HCC) treated with sorafenib.

Medical and Biotech [MESH] Definitions

An ORTHOHEPADNAVIRUS causing chronic liver disease and hepatocellular carcinoma in woodchucks. It closely resembles the human hepatitis B virus.

The type species of the genus ORTHOHEPADNAVIRUS which causes human HEPATITIS B and is also apparently a causal agent in human HEPATOCELLULAR CARCINOMA. The Dane particle is an intact hepatitis virion, named after its discoverer. Non-infectious spherical and tubular particles are also seen in the serum.

The first alpha-globulins to appear in mammalian sera during development of the embryo and the dominant serum proteins in early embryonic life. They reappear in the adult serum during certain pathologic states, primarily hepatocellular carcinoma. They may also be elevated in the amniotic fluid and maternal serum during pregnancy in ANENCEPHALY.

A primary malignant neoplasm of epithelial liver cells. It ranges from a well-differentiated tumor with EPITHELIAL CELLS indistinguishable from normal HEPATOCYTES to a poorly differentiated neoplasm. The cells may be uniform or markedly pleomorphic, or form GIANT CELLS. Several classification schemes have been suggested.

The founding member of the EPH FAMILY RECEPTORS. It was first cloned from an erythropoietin-producing human hepatocellular carcinoma cell line and is highly conserved among many mammalian species. Overproduction of the EphA1 receptor is associated with tumors and tumor cells of epithelial origin. It is also expressed at high levels in LIVER; LUNG; and KIDNEY; which is in contrast to many other members of the Eph receptor that are found primarily in tissues of the nervous system.

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