EUCTR2006-006478-79-DE进行中（未招募）不适用
Study of Radioembolization (RE) with SIR-Spheres® versus Transarterial Chemoembolisation (TACE) in patients with unresectable primary Hepatocellular Carcinoma. A comparative, prospective, randomised, open, pilot trial to evaluate health-related quality of life, pharmaco-economic parameters, and efficacy. - SIRTACE-HCC pilot study
SIRTEX Medical Europe0 个研究点目标入组 28 人开始时间: 2007年5月16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
- 入组人数
- 28
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 unresectable pHCC,
- •diagnosis established according to EASL criteria, and
- •- Liver function: Child-Pugh A
- •- Performance status: ECOG < 2
- •- Tumour lesions: < 5 in number and < 20 cm in cumulative sum of maximum
- •- Life expectancy > 12 weeks
- •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
- •(1) Patients expected to undergo surgery (resection or transplantation) within the
- •24-week period after randomization.
- •(2) Ascites, detectable on physical examination or clinically symptomatic
- •(3) Serum transaminases higher than 5 times the upper normal limit
- •(4) Serum bilirubin > 2 mg/dL
- •(5) Lung shunt > 15%
- •(6) Extrahepatic disease
- •(7) Moderate to severe portal hypertension
- •(10) Impaired renal function (creatinine > 2 mg / dl)
- •(11) Chemotherapy or other experimental therapy within preceding 4 weeks
- •(12) Previous TAE / TACE
- •(13) Previous radiation therapy to liver or lungs
- •(14) Contraindications for angiography (severe peripheral vascular disease or
- •uncorrectable bleeding diathesis)
- •(15) Anatomical variants apparent on 99mTc-MAA scan precluding safe
- •administration of RE
- •(16) Any decompensated concomitant disease
研究者
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