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

Terminated

• Conditions: Hepatocellular Carcinoma
• Interventions: Other: Plasma collection

• Registration Number: NCT03203837
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-06-28
• Study First Posted: 2017-06-29
• Study Start: 2017-07-05
• Primary Completion: 2020-01-06
• Study Completion: 2020-01-06
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-04
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HCC patients	Plasma collection	HCC patients treated with radioembolization. Plasma collection will be performed at 7 timepoints in relation to treatment.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States