NCT07303712

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
6mo left

Started Aug 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Aug 2024Dec 2026

Study Start

First participant enrolled

August 1, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2025

Completed
9 months until next milestone

First Posted

Study publicly available on registry

December 26, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

December 26, 2025

Status Verified

October 1, 2025

Enrollment Period

2 years

First QC Date

March 17, 2025

Last Update Submit

December 18, 2025

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

Circulating tumor cell (CTC)y90

Outcome Measures

Primary Outcomes (2)

  • Circulating Tumor Cell (CTC)

    blood samples

    Baseline, 1 month post treatment, 3 months post treatment, and 6 months post treatment

  • CTA imaging

    imaging of liver tumor

    Baseline, 3 months post treatment, 6 months post treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients at VAPAHCS with HCC

You may qualify if:

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

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, HepatocellularNeoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sirish Kishore, MD

    VA Palo Alto Health Care System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sirish Kishore, MD

CONTACT

650-493-5000sirish.kishore@va.gov

Luisa Manfredi, MPH

CONTACT

650-493-5000luisa.manfredi1@va.gov

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2025

First Posted

December 26, 2025

Study Start

August 1, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 26, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)