About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1: All patients provided voluntary, written informed consent prior to any study procedures.
Disqualifiers
None
Trial population
This study aims to evaluate the impact of baseline emotional status on clinical outcomes in patients with BCLC stage B/C hepatocellular carcinoma receiving HAIC combined with targeted and immunotherapy, providing an evidence-based foundation for developing future clinical strategies integrating physical and mental health interventions.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
progression free survival
Secondary outcomes
Objective response rate
Overall Survival
Disease Control Rate
Sponsors and contacts
Click on the lead sponsor to view all of their trials.