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

NCT03203837 | Terminated

• 1 other identifier: STU000201854
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatocellular Carcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percentage change in angiogenic, inflammatory and immune biomarkers

  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.

  2 years

Secondary Outcomes (4)

• Treatment Response- AFP

  2 years

• Treatment Response - Imaging

  2 years

• Treatment Response- Time-to-Progression

  2 years

• Treatment Response- Overall Survival

  2 years

Study Arms (1)

HCC patients

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

Other: Plasma collection

Interventions

Plasma collection OTHER

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

HCC patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with hepatocellular carcinoma who will be receiving lobar TheraSphere radioembolization.

You may qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• BTG International Inc.: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

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Related Links

• Immunotherapy and Hepatocellular Carcinoma Editorial

Biospecimen

Retention: SAMPLES WITH DNA

Any leftover patient plasma samples collected for this study will be retained for future research which may or may not involve genetic testing.

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Robert Lewandowski, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 29, 2017
• Study Start: July 5, 2017
• Primary Completion: January 6, 2020
• Study Completion: January 6, 2020
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)