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

Tongji Hospital

Status: Not yet enrolling

Conditions: HCC - Hepatocellular Carcinoma

Study type: Observational

Funder types: Other

Identifiers

NCT07117279

TJ-IRB202506074

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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