Actively Recruiting
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
Led by Nanfang Hospital, Southern Medical University · Updated on 2026-02-27
90
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must provide voluntary, written informed consent before any study procedures.
- Participants must be 18 years or older, any gender.
- Patients must have clinically or pathologically confirmed BCLC stage B or C hepatocellular carcinoma and be eligible for hepatic arterial infusion chemotherapy combined with targeted and immunotherapy.
- No prior systemic antitumor therapy received.
- At least one measurable intrahepatic lesion must be present as the primary tumor burden (lesion size ≥ 10 mm or enlarged lymph nodes ≥ 15 mm).
- Child-Pugh score must be 7 or less (Class A or B).
- Able to swallow tablets normally.
- ECOG performance status must be 0 or 1.
- Psychological status and laboratory tests must be fully documented at baseline and during treatment.
- No history of other psychiatric disorders.
You will not qualify if you...
- Presence of any active autoimmune disease or history of autoimmune diseases including autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or vitiligo.
- Current use of immunosuppressants or systemic corticosteroids at doses greater than 10 mg/day prednisone equivalent within 2 weeks before enrollment.
- Known history of central nervous system metastases or hepatic encephalopathy.
- Congenital or acquired immunodeficiency such as HIV infection.
- History or presence of other malignancies in the past 3 years, except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- Current use of antidepressants, anti-anxiety medications, or severe psychiatric disorders requiring other psychotropic drugs.
- Any condition likely to affect study results or cause early study termination, including alcohol or drug abuse, severe co-morbidities, psychiatric disorders requiring treatment, or severe lab abnormalities.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
Research Team
Y
Yuan Guosheng
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here