NCT00707681Unknown2 期
A Phase II Randomized, Controlled Study to Evaluate the Quality of Life, Survival and Therapeutic Benefits of MS-20 in Patient With Advanced Hepatocellular Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate Quality of Life (QoL) score of MS-20 versus placebo in advanced HCC patients
研究概览
简要总结
To evaluate Quality of Life (QoL) score of MS-20 versus placebo in advanced HCC patients using European Organization for Research and Treatment of Cancer (EORTC) QLQ C-30 questionnaire.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects may be included in the study only if they meet all of the following criteria:
- •Subject aged ≧ 20;
- •Histologically documented, unresectable advanced HCC. For patients with difficulty in obtaining histological diagnosis, a "clinical diagnosis" of HCC is acceptable if all the following criteria are met:
- •Chronic hepatitis B or C with evidence of liver cirrhosis;
- •Presence of hepatic tumor(s) with image findings (sonography, CT scan) compatible with HCC and no evidence of gastrointestinal tumors;
- •Elevated serum α-fetoprotein level ≧ 400 ng/ml;
- •Cancer of the Liver Italian Program (CLIP) score of 3-4;
- •Liver transaminase ≦ 5 times upper normal limits (UNL);
- •Patient fulfilling any of the follow conditions:
- •Refuse to receive aggressive cancer therapy after explained to the subjects the benefits and risks;
- •Progressive malignant disease after previous radiotherapy, percutaneous ethanol injection, radiofrequency ablation, transarterial embolization, transarterial chemoembolization, systemic chemotherapy, immunotherapy, or any experimental therapy, or unable to tolerate such therapy;
- •No treatment of high priority is available;
- •ECOG performance status of 0 - 2;
- •Patients are willing and able to comply with study procedures and sign informed consent.
- •Exclusion Criteria
- •Subjects will be excluded from the study for any of the following reasons:
- •Patient with history of HCC rupture;
- •Medical condition requiring anticoagulant or anti-platelet drugs;
- •Patients with brain metastases;
- •Patient unable to receive oral medication;
- •Patients with significant renal function impairment (creatinine>1.5mg/dl), severe cardiac disease, e.g. angina pectoris, myocardial infarction, cardiac arrhythmia, congestive heart failure (New York Heart Association Functional Classification III and IV) or physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that might render the subject at high risk from treatment;
- •Female subjects of childbearing potential who:
- •are lactating; or
- •have positive pregnancy test (urine) at V2;
- •Active infection or on antiretroviral therapy for HIV disease;
- •Patient with known hypersensitivity to any component of the study medication (soy bean or soy product).
排除标准
- 未提供
研究组 & 干预措施
I
Active Comparator
MS-20
干预措施: MS-20 (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate Quality of Life (QoL) score of MS-20 versus placebo in advanced HCC patients
时间窗: 24 weeks
次要结局
- Overall survival, Overall survival rate, Change from baseline of the highest weight observed, Change from baseline of body weight(24 weeks)
研究者
研究点 (1)
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