Clinical trial NCT03203837: Biomarker Analyses in Hepatocellular Carcinoma (HCC) Patients Treated With TheraSphere®
Official title: Biomarker Analyses in Hepatocellular Carcinoma Patients Treated With Therasphere®
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatocellular Carcinoma
Keywords: Radioembolization
Y90
TheraSphere
HCC
Biomarker
Prognostic factor
Angiogenesis
Inflammatory
Liver
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: BTG International Inc.
First posted: 2017-06-29
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with hepatocellular carcinoma who will be receiving lobar TheraSphere radioembolization.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage change in angiogenic, inflammatory and immune biomarkers
timeFrame: 2 years
Secondary outcomes:
measure: Treatment Response- AFP
timeFrame: 2 years
measure: Treatment Response - Imaging
timeFrame: 2 years
measure: Treatment Response- Time-to-Progression
timeFrame: 2 years
measure: Treatment Response- Overall Survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Robert Lewandowski, MD
role: PRINCIPAL_INVESTIGATOR
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