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


Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

90 participants

Start Date

Dec 1, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines how a patient's emotional state — such as depression or anxiety — affects the outcomes of treatment for liver cancer (hepatocellular carcinoma) in people receiving a combination of direct liver artery chemotherapy (HAIC), targeted therapy, and immunotherapy. **You may be eligible if...** - You are 18 or older - You have liver cancer (BCLC stage B or C) confirmed clinically or by biopsy - You are being treated with HAIC combined with targeted and immunotherapy - You have not previously received systemic cancer treatment - You can swallow tablets normally - You are in reasonably good health (ECOG 0-1) **You may NOT be eligible if...** - You have an autoimmune disease or are on immune-suppressing medications - You have had cancer brain metastases or liver failure (hepatic encephalopathy) - You are HIV positive - You have had another cancer in the past 3 years - You are currently taking antidepressants or anti-anxiety medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

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NCT07436845


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