NCT07337031尚未招募不适用
A Randomized Controlled Trial of Complex Behavioral Intervention on Prognostic Survival in Comprehensive Treatment of Patients With Unresectable Liver Cancer
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 193
- 试验地点
- 1
- 主要终点
- Overall survival rate
研究概览
简要总结
Research purpose
- 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.
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •History of psychiatric disorders, severe cognitive impairment, or substance abuse;
- •Previous liver transplantation or treatment for malignant liver tumors;
- •Complete thrombosis of the main portal vein;
- •Female patients who are pregnant or breastfeeding;
- •Presence of severe congenital or acquired immunodeficiency;
- •Unwillingness to sign the informed consent form;
- •Other conditions deemed unsuitable for participation in this study by the investigator.
研究组 & 干预措施
complex intervention group
Experimental
干预措施: complex behavioral intervention (Behavioral)
routine care group
No Intervention
结局指标
主要结局
Overall survival rate
时间窗: The time from enrollment to death caused by any reason, mainly the one-year survival rate
次要结局
- 2-year overall survival rate(The survival rate from enrollment to two years after intervention)
- Progression-Free Survival(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))
- Treatment-related adverse reactions(assessed up to 36 months (this study will last for 36 months))
- Disease-Free Survival(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(assessed up to 36 months (this study will last for 36 months))
- Disease Control Rate(assessed up to 36 months (this study will last for 36 months))
- HCC Quality of life(assessed up to 36 months (this study will last for 36 months))
研究者
Luo Susu
Associate Professor
Eastern Hepatobiliary Surgery Hospital
研究点 (1)
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