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NCT Number: NCT07303712

Liquid Biopsy for Hepatocellular Carcinoma Molecular Characterization After Y90

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).

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Key information

Conditions

Hepatocellular Carcinoma (HCC) Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Cells, Circulating Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location status: Recruiting

Location contact

Sirish Kishore, MD

CONTACT

650-493-5000 ext. 61706

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Primary outcomes

  1. Circulating Tumor Cell (CTC)

    Time frame: Baseline, 1 month post treatment, 3 months post treatment, and 6 months post treatment

    blood samples

  2. CTA imaging

    Time frame: Baseline, 3 months post treatment, 6 months post treatment

    imaging of liver tumor

Study contacts

Contact information is provided by the study sponsor or research team.

Luisa Manfredi, MPH

CONTACT

[email protected]

650-493-5000 ext. 61706

Sirish Kishore, MD

CONTACT

[email protected]

650-493-5000 ext. 61706

Sponsors and collaborators

Lead sponsor

Palo Alto Veterans Institute for Research

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 26, 2025
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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