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Clinical Trial 18924
Interventions:BAY 43-9006 (Sorafenib); Bavituximab (Tarvacin); Sorafenib
Study Type: Treatment
Phase of Study: Phase I
- Jessica Frakes
A Phase I Trial of Sorafenib and Bavituximab Plus Stereotactic Body Radiation Therapy (SBRT) for 1st Line Treatment of Unresectable Hepatocellular Carcinoma
This study involves a course of radiation to up to 5 tumors in the participant's liver followed by systemic therapy. (Treatment using substances that travel through the bloodstream, reaching and affecting cells all over the body.) The type of radiation is called stereotactic body radiation therapy (SBRT). The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given along with the systemic therapies, sorafenib and bavituximab. The researchers want to see which dose of radiation will work best in stimulating the immune response and provide local control to the participant's liver. The usual treatment for hepatocellular carcinoma that is unresectable can be transarterial therapy, sorafenib alone and/or clinical trial.
Primary Objective: To determine the safety and tolerability, describe the dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) (or the highest protocol-defined dose level in the absence of establishing an MTD) of SBRT as part of a combination with sorafenib and bavituximab in patients with multifocal, unresectable HCC. Secondary Objectives: 1. To determine tumor response to the combination. 2. To determine progression free survival following SBRT and sorafenib/bavituximab. 3. To determine overall survival following SBRT and sorafenib/bavituximab. Exploratory Objectives: 1. To correlate radiosensitivity index (RSI) with therapeutic response. 2. To correlate a 12-gene chemokine signature with therapeutic response. 3. To correlate plasma levels of circulating cytokines with therapeutic response. 4. To measure beta2-GP1 and PS-exosome levels.