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

February 23, 2026 updated by: Nanfang Hospital, Southern Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital of Southern Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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

    2: Aged 18 years or older, both male and female.

    3: 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.

    4: No prior systemic antitumor therapy.

    5: 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.);

    6: Child-Pugh score <= 7 (Rated as Child-Pugh class A or B);

    7: Able to swallow tablets normally;

    8: ECOG performance status: 0-1;

    9: Patients' psychological status and laboratory test indicators can be comprehensively documented at baseline and during the treatment period;

    10: All patients have no history of other psychiatric disorders.

Exclusion Criteria:

1. 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).

2: 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.

3: Known history of central nervous system metastases or hepatic encephalopathy.

4: Congenital or acquired immunodeficiency (e.g., HIV infection);

5: 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).

6: Current use of antidepressant or anti-anxiety medications, or severe psychiatric disorders requiring other psychotropic medications.

7: 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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ED
no ED

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression free survival
Time Frame: Baseline（day 1), and after every two treatment cycles（up to 2 years).
Baseline（day 1), and after every two treatment cycles（up to 2 years).

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective response rate
Time Frame: Baseline（day 1), and after every two treatment cycles（up to 2 years).
Baseline（day 1), and after every two treatment cycles（up to 2 years).
Overall Survival
Time Frame: Baseline（day 1), and after every two treatment cycles（up to 2 years).
Baseline（day 1), and after every two treatment cycles（up to 2 years).
Disease Control Rate
Time Frame: Baseline（day 1), and after every two treatment cycles（up to 2 years).
Baseline（day 1), and after every two treatment cycles（up to 2 years).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

February 23, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2025-563

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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