Ireland
--:--IST
Recruiting Observational

Immunophenotype of PBMC to Early Predict Response to Immunotherapy in Hepatocellular Carcinoma

NCT06777628 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-09-15
Last updated
2025-01-16

Condition(s) studied

Liver Cancer, Adult

Investigational drug(s) / intervention(s)

Immunochemotherapy combined with antiangiogenic →

Immunochemotherapy combined with antiangiogenic: Immunochemotherapy combined with antiangiogenic

Study summary

The study is aimed to test the performance of a simple, easy, reproducible cytofluorimetric assay to complement imaging studies for:

* predicting response to immune-therapeutic regimens in HCC in the early phase of treatment,
* to rule out pseudo-progression,
* to early predict the escape from effectiveness of treatment.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * age ≥ 18 years * diagnosis of HCC * execution of laboratory tests and subsequent treatments and follow-up at our center. * obtained written informed consent to the study participation Exclusion Criteria: * immune-related concomitant diseases * HIV infection

Primary outcome measure(s)

  • To find predictive biomarkers of response to immunotherapy in HCC — at 3 month
    Sensitivity and specificity of CD8+, PD1+, PD-L1+, CTLA4+, LAG3+, TIGIT+, CD8+PD1+, CD8+PDL1+ peripheral lymphocytes and granulocytes for tumor response prediction according to RECIST 1.1 criteria

Trial sites (1)

FacilityCityRegionStatus
IRCCS-Azienda Ospedaliero-Universitaria di Bologna Bologna Laura Gramantieri Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06777628 on ClinicalTrials.gov ↗ ← All trials in Italy