Skip to main content
OpenTrials
Completed

NCT Number: NCT06408753

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatocellular Carcinoma Non-resectable Stereotactic Body Radiotherapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Clinical Oncology

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

First Cohort (SBRT+IO):

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

Second Cohort (IO alone):

  • BCLC stage C HCC
  • ECOG performance status 0-1
  • Child-Pugh class A5-B9
  • Adequate organ function

Exclusion criteria

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

Treatment and study plan

sterotatic body radiotherapy

Procedure

checkpoint inhibitors with or without sterotatic body radiotherapy

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
May 10, 2024
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.