Liquid Biopsy for Hepatocellular Carcinoma Molecular Characterization After Y90
NCT07303712 · Phase II · Palo Alto, California, United States
- Condition
- Liver Cancer
- Disease stage
- Stage I-IV
- Phase
- Phase II
- Study type
- Targeted Therapy
- Age
- 18 Years to
- Gender
- All
- Sponsor
- Palo Alto Veterans Institute for Research
- Research institution
- Palo Alto Veterans Institute for Research
- Facility
- VA Palo Alto Health Care System
- Research center
- VA Palo Alto Health Care System
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)
Inclusion criteria
1. Age \> or = 18 years 2. HCC confirmed on imaging, BCLC stage 0, A, B, or C 3. Transarterial Y90 radioembolization approved by multidisciplinary tumor board -
Exclusion criteria
1. Not eligible for Y90 procedure 2. Prior surgery or ablation on indicated tumors 3. Patient unable to complete the follow up visits required for clinical care or research -
Primary outcomes
Circulating Tumor Cell (CTC); CTA imaging