Plasma Biomarker in Predicting Response and Toxicity in Hepatocellular Carcinoma Patients Treated With Checkpoint Inhibitors With or Without Sterotatic Body Radiotherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The University of Hong Kong
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Immune profile of peripheral blood mononuclear cells (PBMC)
Study Overview
Brief 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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- Serum Cytokine profile(from the date of first study treatment to the date of last study treatment, an average of 3 years)
Investigators
Dr. Chi-Leung Chiang
Clinical Assistant Professor
The University of Hong Kong