NCT07303712

Liquid Biopsy for Hepatocellular Carcinoma Molecular Characterization After Y90

Liquid Biopsy for Hepatocellular Carcinoma Molecular Characterization and Assessment of Treatment Response After Y90 Radioembolization: A Pilot Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 12 (estimated)
• Sponsor: Palo Alto Veterans Institute for Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Hepatocellular Carcinoma (HCC)

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2025-12-26
• Last updated: 2025-12-26

Locations

1 site across 1 country: United States