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

Completed

• Conditions: Hepatocellular Carcinoma Non-resectable; Stereotactic Body Radiotherapy

• Registration Number: NCT06408753
• Lead Sponsor: The University of Hong Kong

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2021-09-09
• Primary Completion: 2023-11-30
• Study Completion: 2024-03-27
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-08
• Last Update Submitted: 2024-05-08
• Study First Posted: 2024-05-10
• Last Update Posted: 2024-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immune profile of peripheral blood mononuclear cells (PBMC)	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	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 Outcome Measures

Name	Time	Method
Serum Cytokine profile	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

Trial Locations

Locations (1)

Department of Clinical Oncology; 🇭🇰 Hong Kong, Hong Kong