This study is a multicenter, prospective, observational clinical trial designed to evaluate the impact of baseline emotional status on the clinical outcomes of patients with BCLC stage B/C hepatocellular carcinoma undergoing HAIC combined with targeted immunotherapy. A total of 90 patients are planned to be enrolled and divided into a depressive mood group and a non-depressive mood group based on a PHQ-9/GAD-7 score of ≥5 points. The primary study endpoint is progression-free survival (PFS), and the secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety profile. Dynamic assessments of patients' emotional status, quality of life (EORTC QLQ-C30), and peripheral blood levels of neuroendocrine-immune markers will be conducted at preset time points. The results indicate that emotional status may serve as an important modifiable factor influencing the efficacy of comprehensive therapy in patients with advanced liver cancer, providing an evidence-based basis for the formulation of psychosomatic integrated clinical intervention strategies in the future.
Study Type
OBSERVATIONAL
Enrollment
90
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGprogression free survival
Time frame: Baseline(day 1), and after every two treatment cycles(up to 2 years).
Objective response rate
Time frame: Baseline(day 1), and after every two treatment cycles(up to 2 years).
Overall Survival
Time frame: Baseline(day 1), and after every two treatment cycles(up to 2 years).
Disease Control Rate
Time frame: Baseline(day 1), and after every two treatment cycles(up to 2 years).
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