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

Northwestern University

Status: Terminated

Conditions: Hepatocellular Carcinoma

Treatments: Other: Plasma collection

Study type: Observational

Funder types: Other

Identifiers

NCT03203837

STU000201854

Details and patient eligibility

About

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

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

4 participants in 1 patient group

HCC patients

Description:

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

Treatment:

Other: Plasma collection