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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

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
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113223
Enrollment
Unknown
Registered
2025-11-26
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Interventions

Emotional stress group vs Emotionless stress group:NA

Sponsors

Southern Medical University Southern Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
progression free survival;

Secondary

MeasureTime frame
Objective response rate;Disease control rate;Overall survival;

Countries

China

Contacts

Public ContactJinzhang Chen

Southern Medical University Southern Hospital

chenjinzhang@smu.edu.cn+86 138 0252 2545

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026