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

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

Detailed Description
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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.

Official Title
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Biomarker Analyses in Hepatocellular Carcinoma Patients Treated With Therasphere®

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Other: Plasma collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HCC patients<br>HCC patients treated with radioembolization. Plasma collection will be performed at 7 timepoints in relation to treatment. | Other: Plasma collection<br>* We will be collecting plasma at 7 different timepoints in hepatocellular carcinoma patients that are treated with radioembolization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Response- AFP | Alphafetoprotein will be measured in ng/mL. | 2 years | 
| Treatment Response - Imaging | Lesions will be measured using mRECIST. | 2 years | 
| Treatment Response- Time-to-Progression | Time-to-progression will be measured in days. | 2 years | 
| Treatment Response- Overall Survival | Overall survival will be measured in days. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radioembolization, Y90, TheraSphere, HCC, Biomarker, Prognostic factor, Angiogenesis, Inflammatory, Liver