A Prospective Observational Cohort Study on Dynamic CD8+ T-cell Profiling and Multi-omics Biomarkers for Predicting Conversion Therapy Response in Unresectable Hepatocellular Carcinoma

A Prospective Observational Cohort Study on Dynamic CD8+ T-cell Profiling and Multi-omics Biomarkers for Predicting Conversion Therapy Response in Unresectable Hepatocellular Carcinoma

This study aims to identify early predictors for successful liver cancer treatment conversion. We will track changes in immune cells (CD8+ T-cells) in the blood during chemotherapy infusion (HAIC/TACE) combined with targeted-immunotherapy for 120 patients with unresectable liver cancer. By analyzing blood and tissue samples at multiple timepoints using advanced cell profiling and multi-omics sequencing, we seek to:

Determine if early immune cell changes predict tumor shrinkage; Identify tissue biomarkers linked to longer recurrence-free survival; Build a personalized prediction model for treatment outcomes.

Inclusion Criteria:

• Adults (18-75 years) with histologically confirmed HCC
• At least one measurable lesion ≥10 mm
• Planned HAIC/TACE + immunotherapy regimen
• Child-Pugh class A liver function
• ECOG 0-1
• Signed informed consent

Exclusion Criteria:

• Prior systemic HCC therapy within 6 months
• Main portal vein tumor thrombosis (VP4)
• Active autoimmune disease requiring immunosuppression
• HIV/HBV/HCV with uncontrolled viral replication
• Pregnancy or refusal of contraception