Effect of Sarcopenia on the Efficacy and Prognosis of HCC Treated With Systemic Therapies
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- complications
研究概览
简要总结
Sarcopenia is associated with the prognosis of HCC and cholangiocarcinoma. But there has been rare study focusing on the effect of sarcopenia on the prognosis of HCC treated with systemic therapy, such as interventional therapy, targeted therapy, chemotherapy and immunotherapy and so on.
详细描述
By tracking the short-term and long-term results of HCC patients treated with systemic therapy,the difference of short-term results between patients with sarcopenia and patients without sarcopenia was analyzed, and the correlation between sarcopenia and short-term and long-term results of patients after systemic treatments was explored, so as to improve people's awareness of sarcopenia and pay attention to its prevention and treatment.All implementation details are based on the newest EuropeanWorking Group on Sarcopenia in Older People(EWGSOP) definition. The investigators consecutively admitted patients the questionnaire and evaluated the assessment of muscle strength (grip strength test and chair stand test), muscle quantity (L3 plane total skeletal muscle area) and physical performance (gait test) following the F-A-C-S approach, to confirm patients with sarcopenia accurately. And by tracking the short-term and long-term outcomes, the differences were analyzed and the relationship between sarcopenia and prognosis of systemic treatments was explored.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of hepatocellular carcinoma
- •No cancer other than liver cancer has been diagnosed
- •Age ≥18 years
- •child-pugh score≤7
排除标准
- •uncompleted standard tests and questionnaires
- •received other therapies
- •Patients who had other causes of muscle weakness (injury, fracture, stroke, etc.)
- •Patients who missing CT data or CT scan did not reach the level of the third lumbar vertebra (L3)
- •lost follow-up
结局指标
主要结局
complications
时间窗: 3 months
The complications were classified according to the Clavien-Dindo classification, such as hypertension, fever, abdominal pain and so on.
progression free survival
时间窗: 2 years
Progression free survival was defined as the time from initiation of lenvatinib to first progression or death.
overall survival
时间窗: 2 years
Overall survival was defined as the time from initiation of lenvatinib to death for any reason.
次要结局
- Hospital stay(3 months)
- Hospital cost(3 months)
研究者
Gang Chen, MD
Clinical Professor, Principal Investigator
First Affiliated Hospital of Wenzhou Medical University