Biomarker Analyses in Hepatocellular Carcinoma Patients Treated With Therasphere®
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Percentage change in angiogenic, inflammatory and immune biomarkers
研究概览
简要总结
To analyze specific angiogenic, inflammatory and immune profiles in hepatocellular carcinoma patients who undergo radioembolization.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Patients are excluded if they do not meet the inclusion criteria
结局指标
主要结局
Percentage change in angiogenic, inflammatory and immune biomarkers
时间窗: 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.
次要结局
- Treatment Response- Overall Survival(2 years)
- Treatment Response- AFP(2 years)
- Treatment Response- Time-to-Progression(2 years)
- Treatment Response - Imaging(2 years)
研究者
Robert Lewandowski
MD
Northwestern University