Biomarker Analyses in Hepatocellular Carcinoma (HCC) Patients Treated With TheraSphere®

N/ATerminatedNCT03203837

Northwestern University4 enrolled

Overview

To analyze specific angiogenic, inflammatory and immune profiles in hepatocellular carcinoma patients who undergo radioembolization.

Patients who have planned lobar radioembolization (TheraSphere (TS)) and consent to this study will have peripheral blood samples collected pre-TS, post-TS, 4 hours post-TS, 24 hours post-TS, 3 days post-TS, 7 days post-TS and 30 days post-TS to analyze specific angiogenic, inflammatory and immune profiles.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hepatocellular Carcinoma

Interventions

Plasma collectionOTHER

We will be collecting plasma at 7 different timepoints in hepatocellular carcinoma patients that are treated with radioembolization.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Must have the diagnosis of HCC (biopsy or imaging criteria) * Must have planned lobar TheraSphere treatment * Must be able to give consent * Must have an ECOG (Eastern Cooperative Oncology Group) performance status of ≤ 2 * Must have a life expectancy of ≥ 3 months * Women must not be pregnant with an acceptable contraception in premenopausal women * Must be \> 4 weeks since prior radiation * Must be \> 2 weeks since liver surgery * Must be ≥ 2 weeks post radiosensitizing chemotherapy or \> 6 weeks since prior BCNU (carmustine) or Mitomycin-C Exclusion Criteria: * Patients are excluded if they do not meet the inclusion criteria

Locations (1)

Northwestern University

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Percentage change in angiogenic, inflammatory and immune biomarkers

The percent of change at 7 different timepoints for the following biomarkers will be calculated: Ang-2, FGFb, HB-EGF, HGF, PDGF-BB, PIGF, SDF-1, VEGF, VEGFC, IFNg, IL-1a, IL-1b, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, TNFa trimer, CRP, TGFb1, EGFR, PD-1, PD-L1, CD45RA, CD127, HLA-DR, CD62L, CD3, CD8, CD197, CCR7, CD45RO, PD-L2, FOXP3, Perforin, Granzyme, TIA-1, CD14, CD107a, CD25, CD45, CD4, CD20 and CD56+16.

Time frame: 2 years

Secondary Outcomes

Treatment Response- AFP

Alphafetoprotein will be measured in ng/mL.

Time frame: 2 years

Treatment Response - Imaging

Lesions will be measured using mRECIST.

Time frame: 2 years

Treatment Response- Time-to-Progression

Time-to-progression will be measured in days.

Time frame: 2 years

Treatment Response- Overall Survival

Overall survival will be measured in days.

Time frame: 2 years

Data from ClinicalTrials.gov

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