Clinical trial NCT03889093: Radioembolization of Primary and Secondary Liver Malignancies and The Effect On The Immune System
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hepatocellular Carcinoma
Secondary Malignant Neoplasm of Liver
Keywords: peripheral blood monocytes
cytokine
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 14
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm prospective study
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Biopsy or image (in the setting of hepatocellular carcinoma (HCC)) diagnosed hepatic malignancy
* Total bilirubin \< 2 mg/dL
* ECOG status ≤ 2
* Life expectancy \>3 months as documented in the medical record by the enrolling physician
* Age \>22 years
* Lesion \>2.0 cm which is amenable to percutaneously biopsied

Exclusion Criteria:

* Unwilling or unable to attend all study related follow ups
* Technetium 99 macro aggregated albumin (MAA) lung shunt fraction \>20%
* Arterial anatomy which precludes the ability to safely perform RE
* INR \> 1.8 or platelet count \<50,000 which cannot be corrected
* Patients who are unable to hold anticoagulation and/or antiplatelet therapy in the periprocedural setting

Primary outcomes:
measure: Change in concentrations of PBMC
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in concentrations of cytokines
timeFrame: 1, 4, 12 weeks
measure: Change in concentrations of immune cell infiltration into the tumor
timeFrame: 1, 4, 12 weeks
measure: Change in concentrations of PBMC
timeFrame: 1 and 4 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Shamar J Young, Young
role: PRINCIPAL_INVESTIGATOR
References: