EUCTR2009-013870-42-IT进行中（未招募）不适用
Sorafenib in the first line treatment of advanced hepatocellular carcinoma with ChildPugh liver function class B. Multicentre phase 3 randomized trial - BOOST
ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE0 个研究点开始时间: 2009年10月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •? Patients with diagnosis of HCC according to the AASLD- EASL criteria (10) ? Age >18 years ? Advanced stage of disease defined as HCC not eligible for locoregional treatments (ab initio or following progression after such treatments) ? Liver function classified as Child class B ? ECOG performance status ? 2 ? Adequate renal (creatinine ? 1.5 x ULN), and haematological function (platelet count ? 60 x 10^9/L, hemoglobin ? 9 g/dl) ? Life expectancy of at least 2 months ? Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •? Prior exposure to sorafenib ? Performance Status (ECOG) ?3 ? Concomitant diseases that contraindicates the use of sorafenib ? Gastro-intestinal bleeding in the previous 30 days ? Serious active infections (> grade 2 CTCAE version 3.0) ? Pregnant or lactating women ? Not cooperative patients ? Inability of patients to access to the hospital ? Grade 3-4 encephalopathy that makes the patient not able to follow study procedures (Table 2) ? Refusal of informed consent
研究者
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已完成
2 期
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The efficacy of sorafenib administration prior to TACE against the patients with intermediate HCC refractory to TACEHCCJPRN-UMIN000012636Keio University, School of Medicine10
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Efficacy and Safety of Sorafenib in Previously treated Advanced Hepatocellular Carcinoma: SOPT studyNeoplasmsKCT0006739ational Cancer Center50
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