EUCTR2008-005073-36-GB进行中（未招募）不适用
A randomised placebo-controlled, double blinded, phase III trial of sorafenib in combination with transarterial chemoembolisation in hepatocellular cancer. - TACE-2
niversity College London0 个研究点目标入组 412 人开始时间: 2010年3月15日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 412
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
- •Inclusion Criteria • Histological or cytological diagnosis or meet the AASLD criteria for diagnosis of HCC and at least one uni-dimensional lesion measurable according to the RECIST criteria by CT-scan or MRI. • Not a candidate for surgical resection • Aged = 18 years and estimated life expectancy >3 months • ECOG performance status = 1 • Adequate haematological function Hb = 9g/L, absolute neutrophil count =1.5x109/L, platelet count = 60x109/L • Bilirubin = 50 µmol/L, AST and ALT = 5 x ULN, ALP < 4 x ULN • Adequate renal function; Creatinine = 1.5 x ULN • INR = 1.5 • Amylase < 2 x ULN • Child-Pugh A (score = 6) • Left Ventricular Ejection Fraction = 45% • Women of child-bearing potential should have a negative pregnancy test prior to study entry. Both men and women must be using an adequate contraception method, which must be continued for 3 months after completion of treatment • 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
- •Extrahepatic metastasis • Prior embolisation, systemic or radiation therapy for HCC • Any contraindications for hepatic embolisation procedures procedures including portosystemic shunt, hepatofugal blood flow, known severe atheromatosis. • Investigational therapy or major surgery within 4 weeks of trial entry • Any ablative therapy (RFA or PEI ) for HCC (this should not exclude patients if target lesion(s) have not been treated and occurred >6 weeks prior study entry) • History of bleeding within the past 4 weeks • Child-Pugh cirrhosis C or B (score <7) • Hepatic encephalopathy • Ascites refractory to diuretic therapy • Documented occlusion of the hepatic artery or main portal vein • Hypersensitivity to intravenous contrast agents • Active clinically serious infection > Grade 2 NCI-CTC version 4 • Pregnant or lactating women • Known history of HIV infection • History of second malignancy except those treated with curative intent more than three years preciously without relapse and non-melanotic skin cancer or cervical carcinoma in situ • Evidence of severe or uncontrolled systemic diseases, cardiac arrhythmias (requiring anti-arrhythmic therapy or pace maker), uncontrolled hypertension, congestive cardiac failure >NYHA class 2, MI within 6 months or laboratory finding that in the view of the Investigator makes it undesirable for the patient to participate in the trial • Psychiatric or other disorder likely to impact on informed consent • Patient is unable and/or unwilling to comply with treatment and study instructions • Patient unable to swallow oral medications
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