NCT01092091已完成1 期
Recombinant Human Arginase I (rhArgI) for Patients With Advanced Hepatocellular Carcinoma (HCC)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Tumor response
研究概览
简要总结
The purpose of this study is to determine whether recombinant human arginase (PEG-BCT-100) is safe and effective in the treatment of advanced hepatocellular carcinoma (HCC).
详细描述
The primary objectives of this study are:
- To evaluate any objective tumor responses to PEG-BCT-100 in HCC patients receiving weekly doses of PEG-BCT-100 alone.
- To perform PK and PD analysis
- To measure Quality of Life of the patients
Secondary objectives of this study are:
- To define any toxicity associated with the metabolic and cellular alterations of ADD relative to dose and PK of PEG-BCT-100 (rhArgIpeg5000).
- To confirm the safety and anti-tumor activity of PEG-BCT-100 at the preferred dose (1600U/kg) in 50 patients (at least 18 evaluable subjects) with advanced HCC.
- To measure duration of response including Overall Survival and Time to Progression analysis
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of HCC according to the European Association for the Study of the Liver criteria
- •Known underlying HCC etiology specified by hepatitis B, hepatitis C, post alcoholic cirrhosis, or other
- •HCC lesion(s) which are not resectable and which are measurable by C-T scan
- •Progression of or non-response of HCC lesions after treatments which are considered best standard of care - surgical resection, radiofrequency ablation, chemoembolization
- •No cancer treatment or surgery within the prior 4 weeks, either chemotherapy, targeted biologic or enzymes, either approved or investigational;
- •Males or females from 18 to 75 years-old, inclusive;
- •Ability and willingness to provide written informed consent;
- •Karnofsky performance status of 80% or above and expected survival of more than 12 weeks; and,
- •Negative urine pregnancy test, if female, and willingness to use an effective method of contraception during the entire study period
- •No cognitive impairment
- •Ability to understand and read Chinese
排除标准
- •Advancing liver failure indicated by uncontrolled ascites, pleural effusions, encephalopathy, or a Child-Pugh score of C
- •Significant hepatic, renal or bone marrow dysfunction indicated by total bilirubin >40 µmol/L, evidence of bile duct obstruction, serum albumin <30 g/L, serum SGOT >5 x upper limit of normal, ANC <1.0 x 10^9/L, platelets <100 x 10^9/L, or INR >2.0
- •Significant cardiac or pulmonary disease defined by New York Heart Association (NYHA) Class III or IV, VEF <50% by echo or MUGA, or a history of myocardial infarction within the past 6 months, significant unstable arrhythmia or evidence of ischemia on ECG
- •Pregnant or nursing women. NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •Significant active infection including HIV requiring oral or parenteral anti-infective therapies;
- •Use of investigational drug(s) within 4 weeks of enrollment; or,
- •Prior treatment with arginine depleting agent.
结局指标
主要结局
Tumor response
时间窗: 12 weeks
Tumor response endpoints include(a)Objective response for each patient evaluated by RECIST, (b)Modified RECIST criteria will be used as secondary reference, (c) The proportion of patients achieving a partial response or complete response (d) The proportion of patients reporting disease progression by RECIST and the times to progression (e)Serial changes in plasma AFP levels after doses of PEG-BCT-100 and (f)Change in relevant viral serology from baseline to end-of-study
次要结局
- Overall Survival(12 weeks)
- Time to Progression(12 weeks)
- Plasma arginase level(12 weeks)
- Quality of Life(12 weeks)
- Plasma arginine levels(12 weeks)
研究者
研究点 (1)
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