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

The University of Hong Kong (HKU)

Status: Completed

Conditions: Hepatocellular Carcinoma Non-resectable; Stereotactic Body Radiotherapy

Treatments: Procedure: sterotatic body radiotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT06408753

UW 19-857

Details and patient eligibility

About

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).

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.