Liquid biopsy molecular profiling of hepatocellular carcinoma after Y-90 radioembolization

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

This will test whether blood liquid biopsies (circulating tumor cells and cell-free DNA) taken before and after Y-90 radioembolization can help predict which adults with hepatocellular carcinoma will respond to treatment.

Quick facts

• Study type: Observational
• Enrollment: 12 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Palo Alto Veterans Institute for Research (other)
• Locations: 1 site (Palo Alto, California)
• Trial ID: NCT07303712 on ClinicalTrials.gov

What this trial studies

This observational study will collect baseline and serial blood samples to measure circulating tumor cells (CTCs), single-cell CTC DNA, and cell-free DNA before and over 6–9 months after Y-90 radioembolization. Tumor-derived mutations and temporal changes in CTC/cfDNA will be compared with imaging-based response outcomes at 6–9 months and with radiomic features. Predictive models using liquid biopsy data alone, imaging data alone, and combined multiomic approaches will be developed to identify markers associated with treatment response. The study enrolls adults with BCLC stage 0 through C HCC who are approved for Y-90 by a multidisciplinary tumor board.

Who should consider this trial

Good fit: Adults (≥18 years) with imaging-confirmed hepatocellular carcinoma (BCLC stage 0–C) who are approved for transarterial Y-90 radioembolization and can complete scheduled follow-up visits.

Not a fit: Patients not eligible for Y-90, those with prior surgery or ablation of the target tumors, individuals unable to attend required follow-up, or patients whose tumors do not shed detectable circulating markers are unlikely to benefit.

Why it matters

Potential benefit: If successful, this approach could enable earlier, blood-based prediction of who will benefit from Y-90 and help personalize follow-up and additional therapies.

How similar studies have performed: Prior work has shown that cfDNA and CTC assays can detect HCC mutations and reflect disease burden, but using single-cell CTC DNA dynamics specifically to predict Y-90 response is relatively novel and unproven.

Eligibility criteria

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 -

Where this trial is running

Palo Alto, California

• VA Palo Alto Health Care System — Palo Alto, California, United States (RECRUITING)

Study contacts

• Principal investigator: Sirish Kishore, MD — VA Palo Alto Health Care System
• Study coordinator: Sirish Kishore, MD

Conditions: Hepatocellular Carcinoma, Circulating tumor cell, y90