ACTRN12607000172404已完成1 期
A phase 1 open label dose escalation study to determine safety and tolerability of Clofazimine in Lipiodol (PI-166) injection in patients with unresectable Hepatocellular Carcinoma.
Progen Pharmaceuticals Ltd0 个研究点目标入组 30 人开始时间: 2007年3月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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 ot stated（—）
- 性别
- All
入选标准
- •1. confirmed diagnosis of progressive unresectable hepatocellular carcinoma.2. measurable disease or elevated tumour markers.3. Lipiodol avid tumour.4. Eastern Cooperative Oncology Group Performance Scale 0-2. 5. Voluntary written Informed consent. 6. liver function tests stable within the previous 4 weeks. 7. Patent hepatic artery and portal vein (demonstrated by angiography with in the previous 4 weeks).
排除标准
- •1. Clinically significant non- malignant disease.2. Prior therapy for the primary cancer in the previous 4 weeks (including lipiodol injection).3. Major surgery within the past 4 weeks.4. hepatic encephalopathy or coagulopathy (INR greater than 2)5. Variceal bleeding in the previous 4 weeks6. women who are pregnant or breastfeeding.7.History of allergy and or hypersensitivity to iodine, Lipiodol or clofazimine.8. elevated liver function tests greater than 10 times normal9. uncontrolled infection in the past 4 weeks.
研究者
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