NCT01798147Unknown2 期
Selective Internal Radiotherapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Cholangiocellular Carcinoma (CCC).
Johannes Gutenberg University Mainz2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2011年2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
- 24
- 试验地点
- 2
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
Selective Internal Radiotherapy is superior to Transarterial Chemoembolisation for the treatment of intrahepatic cholangiocellular carcinoma (CCC).
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years
- •Intrahepatic CCC, proven by histology or by typical morphology in cross sectional imaging and elevated tumor markers (CEA or CA 19-9)
- •Tumor confined to the liver
- •At least one measurable lesion in magnetic resonance imaging (MRI)
- •Tumor load ≤ 50%
- •Preserved liver function (Child Pugh A and B)
- •ECOG performance status ≤2
排除标准
- •Patients feasible for curative treatment (e.g. resection or local ablation)
- •Previous TACE or SIRT
- •Prior Chemotherapy
- •Child Pugh stage C
- •ECOG Performance Status >1
- •Tumor involvement >50% of the liver
- •Extrahepatic tumor
- •Serum Bilirubin >2.0 mg/dl; Serum Albumin 2.8 g/dl, Serum Creatinine >2 mg/dl; Leukocytes <3000/ml; Thrombocytes <50000/ml
- •Clinically apparent ascites (ascites only in CT/MRI is no exclusion criteria)
- •Esophageal bleeding during the last 3 months
- •Hepatic encephalopathy
- •Transjugular intrahepatic portosystemic shunt (TIPS)
- •Infiltration or occlusion of the main portal vein
- •Hepatofugal blood flow in the portal vein
- •Hepatopulmonary shunt ≥ 20% in the macroaggregated albumin scan (MAA-scan)
- •Contraindications against angiography
- •Pregnancy
结局指标
主要结局
Progression-free survival (PFS)
时间窗: at the end of study
次要结局
- Overall survival (OS)(at the end of study)
- Time to progression (TTP)(at the end of study)
研究者
Michael Bernhard Pitton
Consultant
Johannes Gutenberg University Mainz
研究点 (2)
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