Plasma Biomarker in Predicting Response and Toxicity in HCC Patients Treated With Checkpoint Inhibitors With or Without SBRT

May 8, 2024 updated by: Dr. Chi-Leung Chiang, The University of Hong Kong

Plasma Biomarker in Predicting Response and Toxicity in Hepatocellular Carcinoma Patients Treated With Checkpoint Inhibitors With or Without Sterotatic Body Radiotherapy

This is a prospective study to investigate the biomarkers in predicting treatment outcome and toxicity in hepatocellular carcinoma (HCC) patients receiving immune checkpoint inhibitors with or without stereotactic body radiotherapy (SBRT).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

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

  • Hong Kong
      • Hong Kong, Hong Kong
        • Department of Clinical Oncology

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Based on the inclusion criteria above. Any eligibility factors that do not fit the inclusion criteria will be considered as ineligible subjects.

Description

Inclusion Criteria:

First Cohort (SBRT+IO):

  1. Unresectable HCC confirmed by multi-disciplinary team
  2. Tumor size 5-15cm
  3. Number of lesion(s) ≤ 3
  4. No main portal vein or inferior vena cava thrombosis
  5. ECOG performance status 0-1
  6. Child-Pugh class A-B7
  7. Liver volume minus gross tumor volume > 700ml
  8. Adequate organ function
  9. No prior systemic therapy, immunotherapy, TACE, radiotherapy, or radio-embolization

Second Cohort (IO alone):

  1. BCLC stage C HCC
  2. ECOG performance status 0-1
  3. Child-Pugh class A5-B9
  4. Adequate organ function

Exclusion Criteria:

1. Based on the inclusion criteria above. Any eligibility factors that do not fit the inclusion criteria will be considered as ineligible subjects.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exosomal PD-L1 level in serum
Time Frame: from the date of first study treatment to the date of last study treatment, an average of 3 years
Increase in level of exosomal PD-L1 may reflect reinvigoration of T-cell activity against cancer cells, thus predicting the treatment efficacy and toxicities in HCC patients received immunotherapy with or without SBRT
from the date of first study treatment to the date of last study treatment, an average of 3 years
Immune profile of peripheral blood mononuclear cells (PBMC)
Time Frame: from the date of first study treatment to the date of last study treatment, an average of 3 years
Immune profile of pre-treatment peripheral blood is predictive of sustained responder of radio-embolization, thus predicting the treatment efficacy and toxicities in HCC patients received immunotherapy with or without SBRT
from the date of first study treatment to the date of last study treatment, an average of 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Cytokine profile
Time Frame: from the date of first study treatment to the date of last study treatment, an average of 3 years
SBRT activates the host immune system, in particular those achieving clinical response to the combined treatment
from the date of first study treatment to the date of last study treatment, an average of 3 years

Collaborators and Investigators

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

Sponsor

The University of Hong Kong

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

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)

November 1, 2019

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

March 27, 2024

Study Registration Dates

First Submitted

September 9, 2021

First Submitted That Met QC Criteria

May 8, 2024

First Posted (Actual)

May 10, 2024

Study Record Updates

Last Update Posted (Actual)

May 10, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 19-857

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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