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Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone

2015-09-30 08:38:22 | BioPortfolio

Summary

This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy.

Description

This is a multi-center, randomized, open-label, Phase 3 study comparing Pexa Vec followed by sorafenib versus sorafenib in patients with advanced HCC without prior systemic therapy.

A total of 600 patients will be randomly assigned to 2 treatment arms in a 1:1 ratio (300 in each arm) to reach at least 570 evaluable patients.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Hepatocellular Carcinoma (HCC)

Intervention

Pexastimogene Devacirepvec (Pexa Vec), Sorafenib

Status

Not yet recruiting

Source

SillaJen, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-09-30T08:38:22-0400

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A Trial to Evaluate the Safety and Efficacy of the Combination of the Oncolytic Immunotherapy Pexa-Vec With the PD-1 Receptor Blocking Antibody Nivolumab in the First-line Treatment of Advanced Hepatocellular Carcinoma (HCC)

This is a study to Evaluate the Safety and Efficacy of the Combination of the Oncolytic Immunotherapy Pexa-Vec With the PD-1 Receptor Blocking Antibody Nivolumab in the First-line Treatmen...

A Study of Recombinant Vaccinia Virus in Combination With REGN2810 for Renal Cell Carcinoma

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Temsirolimus and Sorafenib in Advanced Hepatocellular Carcinoma

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4SC-201 and Sorafenib in Advanced Hepatocellular Carcinoma

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Sorafenib Plus Vitamin K1 Versus Sorafenib in Advanced Hepatocellular Carcinoma

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PubMed Articles [3323 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.

To evaluate the cost-effectiveness of sorafenib treatment in combination with other therapies versus sorafenib monotherapy among patients with advanced hepatocellular carcinoma (HCC) who are enrolled ...

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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