Hepatocellular Carcinoma (HCC)NCT07303712
Liquid Biopsy for Hepatocellular Carcinoma Molecular Characterization After Y90
An observational study of Hepatocellular Carcinoma (HCC), run by Palo Alto Veterans Institute for Research at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at VAPAHCS with HCC
Who may be able to join
- Age > or = 18 years
- HCC confirmed on imaging, BCLC stage 0, A, B, or C
- Transarterial Y90 radioembolization approved by multidisciplinary tumor board -
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Palo Alto Health Care System
Palo Alto, California, 94304
Sirish Kishore, MD, 650-493-5000 ext. 61706
About this study
Official title: 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).
Read the 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)
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- Circulating tumor cell (CTC), y90
- Medical subject headings
- Carcinoma, Hepatocellular, Neoplastic Cells, Circulating
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating Tumor Cell (CTC)
blood samples
Measured: Baseline, 1 month post treatment, 3 months post treatment, and 6 months post treatment
CTA imaging
imaging of liver tumor
Measured: Baseline, 3 months post treatment, 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start1 Aug 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sirish Kishore, MD, Principal investigator, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303712
- Sponsor's protocol ID
- KIS0003ARG
- Status last verified
- Oct 2025
- First submitted
- 17 Mar 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liquid Biopsy for Hepatocellular Carcinoma Molecular Characterization and Assessment of Treatment Response After Y90 Radioembolization: A Pilot Study
- ClinicalTrials.gov ID
- NCT07303712
- Acronym / sponsor ID
- KIS0003ARG
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- Circulating tumor cell (CTC), y90
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at VAPAHCS with HCC
Key inclusion criteria (3 listed)
- Age > or = 18 years
- HCC confirmed on imaging, BCLC stage 0, A, B, or C
- Transarterial Y90 radioembolization approved by multidisciplinary tumor board -
Key exclusion criteria (3 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Circulating Tumor Cell (CTC)
Time frame: Baseline, 1 month post treatment, 3 months post treatment, and 6 months post treatment
blood samples
CTA imaging
Time frame: Baseline, 3 months post treatment, 6 months post treatment
imaging of liver tumor
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sirish Kishore, MD principal investigator
VA Palo Alto Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma (HCC), run by Palo Alto Veterans Institute for Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sirish Kishore, MD (650-493-5000 ext. 61706, sirish.kishore@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating Tumor Cell (CTC) (time frame: Baseline, 1 month post treatment, 3 months post treatment, and 6 months post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.