Liquid Biopsy for Hepatocellular Carcinoma Molecular Characterization and Assessment of Treatment Response After Y90 Radioembolization: A Pilot Study
Summary
The purpose of this study is to determine if baseline liquid biopsy assays (CTC and cf-DNA) as well as single circulating tumor cell-DNA (sCTC DNA) dynamics in the early post-treatment period can predict subsequent treatment response to Y-90 radioembolization in patients with hepatocellular carcinoma (HCC).
Detailed description
Study Aims and Objectives: 1. Assess the detection rate of CTC and cfDNA-based mutations and the distribution of molecular features of HCC prior to Y90 across BCLC A-C stages. 2. Determine CTC and cfDNA predictors at baseline that predict Y90 treatment response at 6-9 months. 3. Determine temporal changes in CTC and cfDNA mutations from baseline over 6-9 month course post Y90. 4. Determine if CTC mean distribution, sCTCDNA, and/or cfDNA mutational dynamic changes are predictive of treatment response at 6-9 months. 5. Assess radiomic and liquid biopsy signatures associated with outcome 6. Compare predictive outcome models using liquid biopsy data, imaging data, or a combination (multiomic data)
Outcome measures
Primary
Circulating Tumor Cell (CTC)
blood samples
Time frame: Baseline, 1 month post treatment, 3 months post treatment, and 6 months post treatment
CTA imaging
imaging of liver tumor
Time frame: Baseline, 3 months post treatment, 6 months post treatment
Eligibility criteria
Study locations (1)
VA Palo Alto Health Care System
Palo Alto, California, 94304