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.
Study Type
OBSERVATIONAL
Enrollment
120
Objective Response Rate (ORR)
Proportion of patients achieving tumor shrinkage (≥30% diameter reduction) or complete disappearance on CT/MRI scans, evaluated by RECIST v1.1 criteria. Complete response = 0 visible tumor; Partial response = ≥30% reduction in total tumor size.
Time frame: From treatment initiation to 12 weeks after first therapy cycle.
Recurrence-Free Survival (RFS)
Time from successful tumor removal surgery to either: (a) new tumor growth on scans, or (b) death from any cause. Verified by quarterly CT/MRI + AFP testing.
Time frame: From surgery date to first recurrence or death (assessed monthly for 24 months).
Severe Treatment-Related Side Effects
Number of patients experiencing grade ≥3 adverse events (e.g., liver damage, low blood counts) confirmed by lab tests and physician evaluation, using CTCAE v5.0 grading.
Time frame: From first treatment dose to 30 days after final dose.
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