A Real-world Study of FGF19 Overexpression Status and Treatment Outcome and Prognosis in Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
A real-world study of FGF19 overexpression status and treatment outcome and prognosis in advanced hepatocellular carcinoma
详细描述
This is a real-world, single-arm, observational study to collect information on the diagnosis and prognosis of hepatocellular carcinoma patients with previous tissue samples in routine clinical practice, and to detect the expression of FGF19 expression in tissue samples, with a view to discovering prognostic and predictive markers for advanced hepatocellular carcinoma The treatment protocol of this study follows the clinical practice and does not set any limitations on the interventions for patients.
In this study, real-world liver tissue samples will be collected from patients with hepatocellular liver cancer after surgical resection, and the samples will be sent to a third-party pathology slice reviewer for review, and a report on the FGF19 expression results will be returned to the project team. Simultaneously collect clinical data of the patient.
According to the principle of clinical routine diagnosis and treatment, the patient's imaging data were collected, and the imaging of the 2-month period was evaluated, and whether the disease progressed was judged according to the RESCIST v1.1 standard. Every two months will be an observation cycle. Each subject will be followed from the first treatment until disease progression or change of drug regimen.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years on the day of signing the informed consent form
- •Histologically or clinically confirmed diagnosis of intermediate to advanced HCC
- •Adequate tissue samples of previous liver cancer
- •Expected survival of more than 3 months
排除标准
- •Fibrous laminae or sarcomatoid HCC or mixed HCC-ICC, or other rare non-HCC pathologic subtypes
- •Other conditions that, in the opinion of the investigator, make participation in this trial inappropriate
结局指标
主要结局
PFS
时间窗: Enrollment until disease progression
PFS was calculated from the date of randomization to the date of the first documented disease progression, with no time constraints involved, marked by the appearance of disease progression
OS
时间窗: Start of enrollment until death (from any cause)
Observation until death from the beginning of participation in the study observation until death from any cause, no time frame limitations were involved. Calculation of OS based on time of death
次要结局
- ORR(Time to enrollment until disease downsizing)
研究者
ZHAO YING
Principal Investigator
Beijing Tsinghua Chang Gung Hospital