Clinical trial NCT06408753: Plasma Biomarker in Predicting Response and Toxicity in HCC Patients Treated With Checkpoint Inhibitors With or Without SBRT
Official title: Plasma Biomarker in Predicting Response and Toxicity in Hepatocellular Carcinoma Patients Treated With Checkpoint Inhibitors With or Without Sterotatic Body Radiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma Non-resectable
Stereotactic Body Radiotherapy
Keywords: SBRT
immune checkpoint inhibitors
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Based on the inclusion criteria above. Any eligibility factors that do not fit the inclusion criteria will be considered as ineligible subjects.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Exosomal PD-L1 level in serum
timeFrame: from the date of first study treatment to the date of last study treatment, an average of 3 years
measure: Immune profile of peripheral blood mononuclear cells (PBMC)
timeFrame: from the date of first study treatment to the date of last study treatment, an average of 3 years
Secondary outcomes:
measure: Serum Cytokine profile
timeFrame: from the date of first study treatment to the date of last study treatment, an average of 3 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Clinical Oncology
Study officials:
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