ACTRN12611001273976已完成未知
Treating patients with colorectal liver metastases or hepatocellular carcinoma with intra-arterial liver isolation chemotherapy delivered through an implantable vascular access system and to determine its feasibility, safety and efficacy.
Dr Rodney Lane0 个研究点目标入组 10 人开始时间: 2011年12月12日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Colorectal cancer liver metastases patients:
- •1) Patients must be over 18 years of age
- •2) Patients must be able to understand the risks and benefits of the trial and give written informed consent to participate
- •3) Patients must be fit for anaesthesia
- •4) Patients must have histologically proven colorectal cancer
- •5) Patients have unresectable hepatic metastases
- •6) Patient has failed first line therapy
- •7) Patients' World Health Organization performance status less than or equal to 2
- •8) Patients have adequate bone marrow
- •9) Patients have adequate renal function
- •10) Patients have adequate liver function
- •11) Patients have normal coagulation
- •Hepatocellular carcinoma patients:
- •1) Patient must be over 18 years of age
- •2) Patients must be able to understand the risks and benefits of the trial and give written informed consent to participate
- •3) Patients must be fit for anaesthesia
- •4) Patients have a Child-Pugh score of A or B
- •5) Patients have failed 1st line therapy
- •6) Patients have adequate hematology/bone marrow
- •7) Patients have adequate liver function
- •8) Patients have normal coagulation
排除标准
- •Colorectal cancer liver metastases patients:
- •1) World Health Organization performance status > 2
- •2) Patients have clinically significant ascites
- •3) Patients have dominant extra-hepatic disease
- •4) Technical inability to perform HAI
- •5) Patients have had previous treatment with SIR spheres
- •6) Patients have Grade 3 or 4 peripheral neuropathy
- •7) Patients have significant co-morbidities
- •Hepatocellular carcinoma patients:
- •1) Child-Pugh score of C
- •2) Patients have dominant extra-hepatic disease
- •3) Patients have had previous treatment with SIR-spheres
- •4) Technical inability to perform HAI
- •5) Patients have significant co-morbidities
- •6) Patients have advanced liver failure/complications
研究者
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