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

NCT07436845 | Recruiting

• 1 other identifier: NFEC-2025-563
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Hepatocellular Carcinoma (HCC); Emotional Distress; HAIC(Hepatic Artery Infusion Chemotherapy); Immunotherapy; Targeted Therapy

Outcome Measures

Primary Outcomes (1)

• progression free survival

  Baseline（day 1), and after every two treatment cycles（up to 2 years).

Secondary Outcomes (3)

• Objective response rate

  Baseline（day 1), and after every two treatment cycles（up to 2 years).

• Overall Survival

  Baseline（day 1), and after every two treatment cycles（up to 2 years).

• Disease Control Rate

  Baseline（day 1), and after every two treatment cycles（up to 2 years).

Study Arms (2)

ED

no ED

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• : All patients provided voluntary, written informed consent prior to any study procedures.
• : Aged 18 years or older, both male and female.
• : Patients with clinically or pathologically confirmed Barcelona Clinic Liver Cancer (BCLC) stage B or C hepatocellular carcinoma, who are deemed eligible for hepatic arterial infusion chemotherapy (HAIC) combined with targeted and immunotherapy as assessed by the clinician.
• : No prior systemic antitumor therapy.
• : At least one intrahepatic evaluable lesion is present, with the intrahepatic lesion constituting the primary tumor burden. (According to RECIST v1.1 criteria, the measurable lesion must have a long diameter \>= 10 mm on spiral CT scan, or enlarged lymph nodes must have a short diameter \>= 15 mm.);
• : Child-Pugh score \<= 7 (Rated as Child-Pugh class A or B);
• : Able to swallow tablets normally;
• : ECOG performance status: 0-1;
• : Patients' psychological status and laboratory test indicators can be comprehensively documented at baseline and during the treatment period;
• : All patients have no history of other psychiatric disorders.

You may not qualify if:

• \. Presence of any active autoimmune disease or history of autoimmune diseases (including, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; childhood asthma that has completely resolved in adulthood and requires no intervention may be included; asthma requiring medical intervention with bronchodilators is excluded).
• : Current use of immunosuppressants or systemic corticosteroid therapy for immunosuppressive purposes (at a dose \>10mg/day of prednisone or equivalent), continuing within 2 weeks prior to enrollment.
• : Known history of central nervous system metastases or hepatic encephalopathy.
• : Congenital or acquired immunodeficiency (e.g., HIV infection);
• : History or presence of other malignancies within the past 3 years (with the exception of cured basal cell carcinoma of the skin and carcinoma in situ of the cervix).
• : Current use of antidepressant or anti-anxiety medications, or severe psychiatric disorders requiring other psychotropic medications.
• : Any other condition deemed by the investigator as likely to affect the study results or lead to premature termination of the study, such as alcohol or drug abuse, other severe co-morbidities (including psychiatric disorders) requiring concomitant treatment, or severe laboratory abnormalities.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Yuan Guosheng

CONTACT

86-020-13268121075; guoshengyuan1991@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 27, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)