Study on Transarterial Chemoembolization Combined With Sorafenib in Chinese Patients With Unresectable Hepatocellular Carcinoma (SUCCESS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 302
- 主要终点
- Summarized patient characteristics
研究概览
简要总结
This study is to obtain the characteristics and treatment pattern of the unresectable HCC patients who are candidates for systemic therapy and in whom a decision to treat with sorafenib from early stage of TACE treatment course (concomitantly use no later than the 3rd TACE procedure) has been made under real-life practice conditions.this study will also conclude the safety and effectiveness of combination in uHCC patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically/ cytologically documented or radiographically diagnosed unresectable HCC who are candidates for systemic therapy and for whom a decision to treat with sorafenib has been made. Radiographic diagnosis needs typical findings of HCC by radiographic method i.e. on multi-dimensional dynamic CT, CT hepatic arteriography (CTHA)/CT arterial portography (CTAP) or MRI;
- •Patients receive the first dose of sorafenib no later than 1 week (<=7days) after the 3rd TACE procedure
- •Patients did not receive other prior systemic treatment by using target therapy
- •Patients must sign the informed consent form;
- •Patients must have a life expectancy of at least 3 months;
- •The physician must be willing to complete and submit all CRFs;
- •The physician must be willing to submit to a site audit with verification of source documents and validation of data reported;
排除标准
- •The first dose of sorafenib 7 days after the 3nd TACE procedure
- •Exclusion criteria must follow the approved local product information
研究组 & 干预措施
Group 1
干预措施: Sorafenib (Nexavar, BAY43-9006) (Drug)
结局指标
主要结局
Summarized patient characteristics
时间窗: up to 3 years
Patient characteristics are hepatic virus infection status, surgery history, tumor size, number of tumor, macroscopic vascular invasion (MVI), extra-hepatic spread (EHS), cirrhosis, ECOG score, Child-Pugh score, BCLC stage, etc.
次要结局
- progression-free survival (PFS) by the mRECIST for treatment of uHCC patients(up to 3 years)
- response rate (RR) by the mRECIST for treatment of uHCC patients(up to 3 years)
- time to progression (TTP) by the mRECIST for treatment of uHCC patients(up to 3 years)
- Clinical control Rate (DCR) by the mRECIST for treatment of uHCC patients(up to 3 years)
- Treatment pattern of Sorafenib(up to 3 years)
- Number of participants with adverse events( AE) and Serious adverse events(SAE) as a measure of safety and tolorability(up to 3 years)
- overall survival (OS) by the mRECIST (Modified Response Evaluation Criteria in Solid Tumor) Criteria for treatment of uHCC patients(up to 3 years)
- Clinical benefit rate (CBR) by the mRECIST for treatment of uHCC patients(up to 3 years)