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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06408753

Enrollment

Registered

2024-05-10

Start date

2019-11-01

Completion date

2024-03-27

Last updated

2024-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma Non-resectable, Stereotactic Body Radiotherapy

Keywords

SBRT, immune checkpoint inhibitors

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).

Interventions

PROCEDUREsterotatic body radiotherapy

checkpoint inhibitors with or without sterotatic body radiotherapy

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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
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

Secondary

Measure	Time frame	Description
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

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026