Outcomes of HCC Patients Treated With TACE Followed or Not Followed by Sorafenib and the Influence of Timing to Initiate Sorafenib
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 1,670
- 试验地点
- 4
- 主要终点
- Overall survival
研究概览
简要总结
This study will collect data of patients who are treated with TACE followed by sorafenib for hepatocellular carcinoma (HCC) or without sorafenib after TACE. In contrast to a prior observational study on sorafenib (GIDEON study, Marrero et al., ASCO 2011), where pre-treatment with TACE was documented retrospectively, this study will collect more detailed information concerning TACE treatments in a prospective manner. This will enable us to evaluate the time to meet criteria for TACE non-eligibility. Outcome of patients will be analyzed in relation to the timing of initiation of sorafenib. It is planned to compare outcome of patients with early start of Sorafenib treatment to those without early start of sorafenib treatment after TACE. In addition, practice patterns of the physicians involved in the care of patients with HCC under real-life conditions will be evaluated.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with histologically/cytologically documented or radiographically diagnosed HCC.
- •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 with BCLC (Barcelona clinic liver cancer staging) stage B or higher.
- •Patients in whom a decision to treat with TACE has been made at time of study enrollment.
- •Patients that have received one TACE in the past also can be enrolled, if the TACE was done at the same site and all required data about such previous TACEs are available.
- •TACE includes both conventional TACE with lipidiol (or similar agents) and chemotherapeutic agent(s) and TACE with DC Beads excluding TAE without chemotherapeutic agent.
- •Patients with unresectable HCC (incurable with curative treatments including resection or ablation or not eligible for resection or local ablation) Patients must have signed an informed consent form Patients must have a life expectancy of at least 8 weeks.
排除标准
- •Patients who have received TACE in the past but the data about TACE required in this protocol are not available Patients who received any systemic anti-cancer therapy prior to the first TACE Patients who are treated according to a trial protocol for intervention including a locoregional therapy or systemic therapy Hospice patients All contra-indications according to the local marketing authorization should be considered.
结局指标
主要结局
Overall survival
时间窗: Time Frame: Up to 3 years
次要结局
- Progression-free survival from initial TACE(Time Frame: Up to 3 years)
- Tumor response according to mRECIST criteria(Time Frame: Up to 3 years)
- Duration of treatment(Time Frame: Up to 3 years)
- Overall survival from initial TACE(Time Frame: Up to 3 years)
- Time to progression from initial TACE(Time Frame: Up to 3 years)
- Number of patients with TEAEs (treatment emergent adverse events)(Time Frame: Up to 3 years)