Trials / Recruiting

RecruitingNCT07436845

Impact of Emotional Status on Prognosis of Patients With BCLC Stage B/C Hepatocellular Carcinoma Undergoing Hepatic Arterial Infusion Chemotherapy Combined With Targeted and Immunotherapy

Impact of Emotional Status on Prognosis of Patients With BCLC Stage B/C Hepatocellular Carcinoma Undergoing Hepatic Arterial Infusion Chemotherapy Combined With Targeted and Immunotherapy: A Multicenter, Prospective, Observational Clinical Study

Status: Recruiting
Phase: —
Study type: Observational
Enrollment: 90 (estimated)

Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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.

Conditions

Timeline

Start date: 2025-12-01
Primary completion: 2028-01-01
Completion: 2028-01-01
First posted: 2026-02-27
Last updated: 2026-02-27

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07436845. Inclusion in this directory is not an endorsement.