Data from Clinical Trials - Curated by Toby Galbraith - Last updated 21 April 2017

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).

purpose

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 Outcome Measures:

  • Occurrence of Treatment Related Adverse Events [ Time Frame: From beginning of treatment to 30 days post-treatment, approximately 2 years ]
    • Safety and tolerability, as assessed by presence of adverse events, serious adverse events, dose limiting toxicity (DLTs), abnormal laboratory parameters, vital signs. A DLT is defined as any toxicity not attributable to the disease or disease-related processes under investigation, which occurs from the start of radiation up to 42 days and is considered by the Investigators to be definitely, probably, or possibly related to the treatment. A DLT will be defined as any Grade 3 or higher treatment-related toxicity that occurs during the DLT evaluation period.

Secondary Outcome Measures:

  • Objective Response Rate (ORR) [ Time Frame: Up to 24 months post treatment ]
    • Tumor response data will be summarized for dosed participants with measurable disease at baseline. Response will be evaluated using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. In addition, the immune response criteria will be utilized.
  • Progression Free Survival (PFS) [ Time Frame: Up to 24 months post treatment ]
    • PFS following SBRT, sorafenib, and bavituximab, will be summarized in the expansion phase arm. Progression will be evaluated using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.) In addition, the immune response criteria will be utilized.
  • Overall Survival (OS) [ Time Frame: Up to 24 months post treatment ]
    • Overall Survival following SBRT, sorafenib, and bavituximab. OS: The length of time from beginning of study treatment to death from any cause.
Category Value
Date last updated at source 31-Mar-17
Recruiting in United States of America
Study type(s) Interventional
Expected enrolment 18
Study start date 27-Mar-17
Estimated primary completion date 01-Jan-20

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