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

Официальное название

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

Обзор

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.

Первичные конечные точки

• progression free survival [Срок оценки: Baseline（day 1), and after every two treatment cycles（up to 2 years).]

Вторичные конечные точки (3)

• Objective response rate [Срок оценки: Baseline（day 1), and after every two treatment cycles（up to 2 years).]
• Overall Survival [Срок оценки: Baseline（day 1), and after every two treatment cycles（up to 2 years).]
• Disease Control Rate [Срок оценки: Baseline（day 1), and after every two treatment cycles（up to 2 years).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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.

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Nanfang Hospital of Southern Medical University — Гуанчжоу

Идентификаторы

NCT: NCT07436845 · NFEC-2025-563

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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