NCT01556815Unknown2 期
Phase II Trail of Sorafenib Combined With Transarterial Chemoembolization in HBV-infected Patients With Intermediate Hepatocellular Carcinoma
Shandong Cancer Hospital and Institute1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年5月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Effectiveness of sorafenib in increasing the effectiveness of transarterial chemoembolization (TACE)
研究概览
简要总结
Transarterial chemoembolization (TACE) is widely used for unresectable hepatocellular carcinoma (HCC). However, the hypoxia caused by TACE in surviving tumor cell leads to release of angiogenic and growth factors contributing to poor outcome. Sorafenib can block tumor cell proliferation and angiogenesis. The hypothesis is that patients with unresectable HCC may benefit from sorafenib in combination with TACE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients newly diagnosed as HCC according to European Association for Study of the Liver criteria.
- •BCLC stage B
- •Child-Pugh class A
- •ECOG performance status of 0
- •Etiology: Hepatitis B virus(HBV) infection
- •Written informed consent (approved by the Institutional Review Board [IRB]obtained prior to any study specific screening procedures
- •Patient must be able to comply with the protocol
- •Age 18-80 years
- •Haematology:Absolute neutrophil count (ANC) > 1 x 109/L, Platelet count > 40 x 109/L, Haemoglobin > 9 g/dL (may be transfused to maintain or exceed this level) Prothrombin time international normalized ratio < 1.5
- •Biochemistry:Total bilirubin < 2 mg/dL Serum creatinine < 1.5 x the upper limit of normal
- •Life expectancy of > 3 months
排除标准
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5 x the upper limit of normal
- •Other severe concomitant disease that may reduce life expectancy
- •uncontrolled hypertension
- •Pregnancy (positive serum pregnancy test) or lactation
- •Uncontrolled hypertension
- •Serious, non-healing wound, ulcer, or bone fracture
- •Currently or recent (within the 30 days prior to starting study treatment) treatment of another investigational drug or participation in another investigational study
- •Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents ( ≤ 6 months prior to study entry), myocardial infarction ( ≤ 6 months prior to study entry), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication
- •Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of Sorafenib/TACE or patient at high risk from treatment complications
结局指标
主要结局
Effectiveness of sorafenib in increasing the effectiveness of transarterial chemoembolization (TACE)
时间窗: 1 year
Measure:time-to-proression
次要结局
- safety of sorafenib in combination with TACE(6 months)
- Survival in the two treatment groups(2 years)
研究者
Jinlong Song
Chief, Division of Interventional Therapy
Shandong Cancer Hospital and Institute
研究点 (1)
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