NCT01251458已完成1 期
Phase I/II Study of Temsirolimus (Torisel®) as Novel Therapeutic Drug for Patients With Unresectable Hepatocellular Carcinoma (HCC)- A Correlative Study With Stathmin Over-expression
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- • To establish the maximum tolerated dose (MTD) and a suitable dose for Phase II evaluation of Torisel® given as a weekly dose in patients with advanced hepatocellular carcinoma (HCC)
研究概览
简要总结
This is a phase I/II study to evaluate dose limited toxicity and efficacy of Torisel
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically confirmed hepatocellular carcinoma that is not amenable to curative resection
- •measurable disease
- •Age >=18 years.
- •Life expectancy of greater than 12 weeks.
- •ECOG performance status <= 2
- •Prior systemic therapy for HCC is allowed
- •Adequate haematologic, renal and hepatic function
- •Absence of cirrhosis or Child's A cirrhosis
- •Fasting total cholesterol <9.1 mmol/liter and fasting triglyceride level <4.5 mmol/liter)
排除标准
- •Patients who have had systemic therapy or radiotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier.
- •Patients receiving any other investigational agents concurrently.
- •Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- •Uncontrolled intercurrent diseases such as, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant women.
研究组 & 干预措施
Torisel
Experimental
干预措施: Torisel (Drug)
结局指标
主要结局
• To establish the maximum tolerated dose (MTD) and a suitable dose for Phase II evaluation of Torisel® given as a weekly dose in patients with advanced hepatocellular carcinoma (HCC)
时间窗: 2 years
次要结局
- • To determine duration of response (DR)(2 years)
- • To determine and establish the safety and toxicity profile of Torisel® and to identify any dose limiting toxicities (DLTs) in advanced HCC(2 Years)
- • To determine the response rate (CR and PR) based on RECIST criteria(2 years)
- • To determine progression-free survival (PFS) in patients with advanced hepatocellular carcinoma (HCC) treated with Torisel®(4 Years)
- • To correlate stathmin expression in pre-treatment HCC tumour biopsies and clinical response to Torisel®(2 years)
- • To determine clinical benefit rate (CBR, percent of patients experiencing CR, PR or SD ≥ 12 weeks)(2 years)
- • To determine overall survival (OS)(4 years)
研究者
CCTU
Comprehensive Clinical Trial Unit
Chinese University of Hong Kong
研究点 (1)
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