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

Qualifiers

1: All patients provided voluntary, written informed consent prior to any study procedures.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

90 Participants
are grouped into 2 trial groups

Locations

1
Nanfang Hospital of Southern Medical University510515, GuangzhouGuangdong, China

Sponsors and collaborators

Nanfang Hospital, Southern Medical University

Lead sponsor