Biomarker Analyses in Hepatocellular Carcinoma (HCC) Patients Treated With TheraSphere®

Biomarker Analyses in Hepatocellular Carcinoma Patients Treated With Therasphere®

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03203837

Enrollment

Registered

2017-06-29

Start date

2017-07-05

Completion date

2020-01-06

Last updated

2020-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

Radioembolization, Y90, TheraSphere, HCC, Biomarker, Prognostic factor, Angiogenesis, Inflammatory, Liver

Brief summary

To analyze specific angiogenic, inflammatory and immune profiles in hepatocellular carcinoma patients who undergo radioembolization.

Detailed description

Patients who have planned lobar radioembolization (TheraSphere (TS)) and consent to this study will have peripheral blood samples collected pre-TS, post-TS, 4 hours post-TS, 24 hours post-TS, 3 days post-TS, 7 days post-TS and 30 days post-TS to analyze specific angiogenic, inflammatory and immune profiles.

Interventions

OTHERPlasma collection

We will be collecting plasma at 7 different timepoints in hepatocellular carcinoma patients that are treated with radioembolization.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Must have the diagnosis of HCC (biopsy or imaging criteria) * Must have planned lobar TheraSphere treatment * Must be able to give consent * Must have an ECOG (Eastern Cooperative Oncology Group) performance status of ≤ 2 * Must have a life expectancy of ≥ 3 months * Women must not be pregnant with an acceptable contraception in premenopausal women * Must be \> 4 weeks since prior radiation * Must be \> 2 weeks since liver surgery * Must be ≥ 2 weeks post radiosensitizing chemotherapy or \> 6 weeks since prior BCNU (carmustine) or Mitomycin-C

Exclusion criteria

* Patients are excluded if they do not meet the inclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Percentage change in angiogenic, inflammatory and immune biomarkers	2 years	The percent of change at 7 different timepoints for the following biomarkers will be calculated: Ang-2, FGFb, HB-EGF, HGF, PDGF-BB, PIGF, SDF-1, VEGF, VEGFC, IFNg, IL-1a, IL-1b, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, TNFa trimer, CRP, TGFb1, EGFR, PD-1, PD-L1, CD45RA, CD127, HLA-DR, CD62L, CD3, CD8, CD197, CCR7, CD45RO, PD-L2, FOXP3, Perforin, Granzyme, TIA-1, CD14, CD107a, CD25, CD45, CD4, CD20 and CD56+16.

Secondary

Measure	Time frame	Description
Treatment Response- Time-to-Progression	2 years	Time-to-progression will be measured in days.
Treatment Response- AFP	2 years	Alphafetoprotein will be measured in ng/mL.
Treatment Response - Imaging	2 years	Lesions will be measured using mRECIST.
Treatment Response- Overall Survival	2 years	Overall survival will be measured in days.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026