Radioembolization of Primary and Secondary Liver Malignancies and The Effect On The Immune System

Hepatocellular Carcinoma Clinical Trial

Official title: Radioembolization of Primary and Secondary Liver Malignancies and The Effect On The Immune System: A Prospective Study of Cytokine Modulation And Immune Cell Infiltration

Status Recruiting

Clinical Trial Summary

The goal of this study is to understand the immunologic effects radioembolization has on the immune system. This will be done by evaluating the changes on biopsy, peripheral blood monocytes, and cytokines.

Clinical Trial Description

This is a single institution non-interventional study designed to evaluate the immune reaction to radioembolization (RE) of primary and secondary malignancies of the liver.

RE has been established as a standard of care treatment for both primary and secondary cancers of the liver. The treatment consists of a mapping, or planning angiogram, followed by a delivery angiogram where the dose of yttrium 90 (y90) is delivered. Data has been published on the immune modification powers of external beam radiation (XRT). However, very little data is available on the ways in which RE modifies the immune system. The goal of this study is to determine changes in the peripheral blood monocytes, cytokines and the treated and untreated liver tumors through sample collection prior to and for 12 weeks after standard of care RE.

The prior to, the RE delivery procedure patients will have a blood draw to evaluate for levels of 11 immunologically relevant cytokines (IL-1α, IL-1β, IL-2, IL-6, IL-10, IL-12p70, IL-18, TNFα, IFN-ϒ, Fit ligand 3, and MCP-1). These blood draws will be repeated at 7 days (- 2 days, + 5 days), 4 weeks (± 2 weeks) and 12 weeks (± 2 weeks) after RE.

The patients will also have the infiltration of immune relative cells into treated tumors evaluated. This will be done by the patients undergoing biopsy of the largest tumor to be treated prior to treatment and at 2 weeks (±7 days) following RE. If patients have other areas of tumor, which are not included in the initial treatment site, these areas will also be biopsied.

Finally, the change in immunologically important peripheral lymphocytes will be collected. This will be done with a blood draw on the day of, but prior to RE serving as an internal control. Patients will then also have blood draws performed at 7 days (±2 days), 4 weeks (± 2 weeks) and 12 weeks (± 2 weeks) after RE. ;

Related Conditions & MeSH terms

• Hepatocellular Carcinoma
• Liver Neoplasms
• Neoplasm Metastasis
• Neoplasms
• Secondary Malignant Neoplasm of Liver

• NCT number: NCT03889093
• Study type: Interventional
• Source: University of Minnesota
• Contact: Shamar J Young, MD
• Phone: 612-626-5566
• Email: youn1862@umn.edu
• Status: Recruiting
• Phase: N/A
• Start date: August 9, 2018
• Completion date: June 1, 2024