Liquid Biopsy for Hepatocellular Carcinoma Molecular Characterization After Y90

Palo Alto Veterans Institute for Research

Status: Enrolling

Conditions: Hepatocellular Carcinoma (HCC)

Study type: Observational

Funder types: Other

Identifiers

NCT07303712

KIS0003ARG

Details and patient eligibility

About

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).

Full 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)

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 -

Trial design