NCT01308645Unknown2 期
PhaseⅡ, Open Label, Clinical Trial to Investigate Safety and Efficacy of SB Injection in Patients With Advanced or Primary Hepatocellular Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Evaluating Tumor Response Rate
研究概览
简要总结
The purpose of this study is to determine efficacy of SB injection in Hepatocellular Carcinoma (HCC).
详细描述
All eligible patients will receive SB injection therapy for 6 cycles (14~21 days for each cycle). Efficacy wll be evaluated every 3 cycles.
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
- •Age of 18 years or over
- •Patients with Hepatocellular carcinoma progression (HCC) and primary liver cancer as a diagnostic imaging test (eg, X-ray, CT, scan, ultrasound) can be measured in patients with a lesion
- •Directly to standard therapy (surgery, RF ablation, TACE) is not possible, patients with advanced liver cancer. However, the standard treatment of the subject or subjects entirely voluntary participation of subjects participating at the discretion of the doctor or researcher can be deemed included in the selected target.
- •Life expectancy ≥ 5 months
- •ECOG status 0, 1, 2 patients
- •Child-Pugh classification A, B patients
- •PLT 70,000, ANC 1,000 or more patients (OT / PT <upper normal limit x 5.0, Bilirubin <upper normal limit x 3.0)
- •Female volunteers admitted to the study must be using a reliable means of contraception and must have a negative blood or urine pregnancy test at least 7 days ago
- •Patients or their legal representatives who have signed the informed consent form
排除标准
- •Last 4 weeks the patients who had participated in another clinical trial
- •Last 4 weeks the patients who received chemotherapy
- •Associated with hepatocellular carcinoma in patients with a history of malignant tumor
- •Hepatectomy or liver transplantation patients who received treatment.
- •Active systemic infection requiring medical treatment
- •Uncontrolled hypertension or diabetes mellitus.
- •Clinically Significant cardiac disease (myocardial infarction / angina / severe arrhythmia / congestive heart failure)
- •Autoimmune diseases (systemic lupus erythematosus: SLE / rheumatoid arthritis / myasthenia gravis) and the patients currently being treated
- •Presence or history of malignancy other than Hepatocellular carcinoma within 5 years
- •Patients who have history of allergy with this investigational drug.
- •Obvious cognitive or physical impairment that would prevent participation
- •Pregnancy, lactation period and don't using contraception earnest Patients
结局指标
主要结局
Evaluating Tumor Response Rate
时间窗: 4 Months
次要结局
- Pain Scores on the Visual Analog Scale(4 Months)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability scale(4 Months)
- Determine duration of response rate by measuring time to progression(4 Months)
研究者
研究点 (2)
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