Biomarker Analyses in Hepatocellular Carcinoma Patients Treated With Therasphere®
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- Northwestern University
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Percentage change in angiogenic, inflammatory and immune biomarkers
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
To analyze specific angiogenic, inflammatory and immune profiles in hepatocellular carcinoma patients who undergo radioembolization.
Detailed Description
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.
Investigators
Robert Lewandowski
MD
Northwestern University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Percentage change in angiogenic, inflammatory and immune biomarkers
Time Frame: 2 years
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.
Secondary Outcomes
- Treatment Response- Overall Survival(2 years)
- Treatment Response- AFP(2 years)
- Treatment Response- Time-to-Progression(2 years)
- Treatment Response - Imaging(2 years)