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

September 4, 2020 updated by: Robert Lewandowski, Northwestern University

Biomarker Analyses in Hepatocellular Carcinoma Patients Treated With Therasphere®

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HCC patients
HCC patients treated with radioembolization. Plasma collection will be performed at 7 timepoints in relation to treatment.
Other: Plasma collection
We will be collecting plasma at 7 different timepoints in hepatocellular carcinoma patients that are treated with radioembolization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage change in angiogenic, inflammatory and immune biomarkers
Time Frame: 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.
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

BTG International Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2017

Primary Completion (Actual)

January 6, 2020

Study Completion (Actual)

January 6, 2020

Study Registration Dates

First Submitted

June 20, 2017

First Submitted That Met QC Criteria

June 28, 2017

First Posted (Actual)

June 29, 2017

Study Record Updates

Last Update Posted (Actual)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 4, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU000201854

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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