Liquid Biopsy for Hepatocellular Carcinoma Molecular Characterization After Y90

December 18, 2025 updated by: Palo Alto Veterans Institute for Research

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

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).

Study Overview

Status

Recruiting

Conditions

Hepatocellular Carcinoma (HCC)

Detailed Description

Study Aims and Objectives:

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.
Determine CTC and cfDNA predictors at baseline that predict Y90 treatment response at 6-9 months.
Determine temporal changes in CTC and cfDNA mutations from baseline over 6-9 month course post Y90.
Determine if CTC mean distribution, sCTCDNA, and/or cfDNA mutational dynamic changes are predictive of treatment response at 6-9 months.
Assess radiomic and liquid biopsy signatures associated with outcome
Compare predictive outcome models using liquid biopsy data, imaging data, or a combination (multiomic data)

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Sirish Kishore, MD
Phone Number: 61706 650-493-5000
Email: sirish.kishore@va.gov

Study Contact Backup

Name: Luisa Manfredi, MPH
Phone Number: 61706 650-493-5000
Email: luisa.manfredi1@va.gov

Study Locations

United States
- California
  - Palo Alto, California, United States, 94304
    - Recruiting
    - VA Palo Alto Health Care System
    - Contact:
      
      Sirish Kishore, MD
      
      Phone Number: 61706 650-493-5000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

Patients at VAPAHCS with HCC

Description

Inclusion Criteria:

Age > or = 18 years
HCC confirmed on imaging, BCLC stage 0, A, B, or C
Transarterial Y90 radioembolization approved by multidisciplinary tumor board -

Exclusion Criteria:

Not eligible for Y90 procedure
Prior surgery or ablation on indicated tumors
Patient unable to complete the follow up visits required for clinical care or research -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circulating Tumor Cell (CTC) Time Frame: Baseline, 1 month post treatment, 3 months post treatment, and 6 months post treatment	blood samples	Baseline, 1 month post treatment, 3 months post treatment, and 6 months post treatment
CTA imaging Time Frame: Baseline, 3 months post treatment, 6 months post treatment	imaging of liver tumor	Baseline, 3 months post treatment, 6 months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Palo Alto Veterans Institute for Research

Investigators

Principal Investigator: Sirish Kishore, MD, VA Palo Alto Health Care System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 17, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Actual)

December 26, 2025

Study Record Updates

Last Update Posted (Actual)