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

Last updated: May 8, 2024
Sponsor: The University of Hong Kong
Overall Status: Completed

Phase

N/A

Condition

Carcinoma

Treatment

sterotatic body radiotherapy

Clinical Study ID

NCT06408753
UW 19-857
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

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):
  10. BCLC stage C HCC
  11. ECOG performance status 0-1
  12. Child-Pugh class A5-B9
  13. Adequate organ function

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: sterotatic body radiotherapy
Phase:
Study Start date:
November 01, 2019
Estimated Completion Date:
March 27, 2024

Connect with a study center

  • Department of Clinical Oncology

    Hong Kong,
    Hong Kong

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.