A Trial of Behavioral Intervention on Prognostic Survival of Patients With Unresectable Liver Cancer

Официальное название

A Randomized Controlled Trial of Complex Behavioral Intervention on Prognostic Survival in Comprehensive Treatment of Patients With Unresectable Liver Cancer

Обзор

Research purpose 1. To evaluate the impact of complex behavioral intervention on the one-year overall survival rate of patients with unresectable liver cancer after comprehensive treatment, a comparative study was conducted between the complex behavioral intervention group and the standard medical care control group, and the dose-response relationship between the intervention intensity and clinical outcomes was explored. 2. Analyze the impact mechanisms of complex behavioral interventions on patients' quality of life, adverse treatment reactions, and key biological indicators, including evaluating clinical outcomes such as 2-year overall survival rate, progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR), as well as the association between changes in related biomarkers and behavioral compliance. 3. Evaluate the implementation effect and sustainability of the "in-hospital face-to-face + wechat platform" hybrid intervention model, including intervention acceptance, long-term behavior maintenance, health economic benefits, and perioperative recovery of patients undergoing down-conversion surgery.

Вмешательства

• Поведенческое complex behavioral intervention
  Including behavioral intervention measures such as alcohol cessation management, smoking cessation and respiratory function training, nutrition management, exercise management, blood sugar and weight management, sleep management, pain management, wound and infection management, mindfulness meditation and mental health management.

Первичные конечные точки

• Overall survival rate [Срок оценки: The time from enrollment to death caused by any reason, mainly the one-year survival rate]

Вторичные конечные точки (7)

• 2-year overall survival rate [Срок оценки: The survival rate from enrollment to two years after intervention]
• Progression-Free Survival [Срок оценки: The time from enrollment to disease progression (according to the mRECIST 2010 version) or death caused by any reason, assessed up to 36 months (this study will last for 36 months)]
• Disease-Free Survival [Срок оценки: From the date of surgery to disease recurrence, progression, or death due to any cause, whichever occurs first, assessed up to 36 months (this study will last for 36 months)]
• Objective Response Rate [Срок оценки: assessed up to 36 months (this study will last for 36 months)]
• Disease Control Rate [Срок оценки: assessed up to 36 months (this study will last for 36 months)]
• Treatment-related adverse reactions [Срок оценки: assessed up to 36 months (this study will last for 36 months)]
• HCC Quality of life [Срок оценки: assessed up to 36 months (this study will last for 36 months)]

Критерии участия

Критерии включения

• Pathologically or radiologically confirmed primary hepatocellular carcinoma;
• BCLC stage B-C, initially assessed as unresectable;
• Age 18-75 years;
• ECOG performance status score 0-2;
• Child-Pugh classification grade A or B (<=9 points);
• Normal cognitive ability, capable of understanding and following intervention protocols;
• Both the patient and primary caregiver can use a smartphone and the WeChat platform and are able to complete questionnaires and follow-up tasks;
• Voluntarily participates in the study and signs the informed consent form.

Критерии исключения

• Presence of malignant tumors in other organs;
• Presence of extrahepatic metastasis;
• Presence of any of the following severe organic diseases in any organ:

(1) Cardiovascular: NYHA class III-IV heart failure, acute coronary syndrome within the past 6 months; (2) Liver: Child-Pugh class C cirrhosis, or ALT/AST >5 times the upper limit of normal; (3) Kidney: eGFR <45 mL/min/1.73m\^2 or dialysis-dependent; (4) Respiratory: respiratory failure requiring long-term oxygen therapy; (5) Hematologic: hemoglobin <9 g/dL or platelets <75×10\^9/L; 4. History of psychiatric disorders, severe cognitive impairment, or substance abuse; 5. Previous liver transplantation or treatment for malignant liver tumors; 6. Complete thrombosis of the main portal vein; 7. Female patients who are pregnant or breastfeeding; 8. Presence of severe congenital or acquired immunodeficiency; 9. Unwillingness to sign the informed consent form; 10. Other conditions deemed unsuitable for participation in this study by the investigator.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 1 центр

• Eastern Hepatobiliary Surgery Hospital — Шанхай

Идентификаторы

NCT: NCT07337031 · 25ZR1402578

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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