NCT05200221Unknown不适用
A Single Center Real-world Study of Donafenib in the Treatment of Hepatocellular Carcinoma (HCC) in Routine Clinical Practice
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年1月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Incidence of adverse events and serious adverse events.
研究概览
简要总结
This trial is a single center observational real-world study. It is planned to include 300 patients with unresectable hepatocellular carcinoma (uHCC) treated with Donafenib. The purpose of the study was to observe the effectiveness and safety of Donafenib in the real world.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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 old;
- •Histologically confirmed HCC or meet the clinical diagnostic criteria of HCC;
- •Unresectable HCC;
- •The doctor decided to use donafenib before the patient was enrolled in the study；
- •Informed consent and willing to complete the study according to the protocol.
排除标准
- •Those who are participating in clinical trials of other antitumor drugs;
- •Allergic to any component of Donafenib tablets;
- •Patients with active bleeding, active peptic ulcer, drug uncontrollable hypertension or severe liver dysfunction;
- •Pregnant or lactating women.
结局指标
主要结局
Incidence of adverse events and serious adverse events.
时间窗: an average of 1.5 year.
Incidence of adverse events and serious adverse events.
次要结局
- Duration of remission (DoR)(an average of 1 year.)
- Objective response rate (ORR)(an average of 1 year.)
- Disease control rate (DCR)(an average of 1 year)
- overall survival(OS)(an average of 1 year)
- Progression-free survival(PFS)(an average of 1 year)
研究者
研究点 (1)
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