NCT01259193Unknown2 期
Phase II Study of Sorafenib and Zoledronic Acid in Advanced HCC
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- numbers of adverse events
研究概览
简要总结
Sorafenib ,an oral multikinase inhibitor targeting several tyrosine-kinase receptors with antiangiogenesis and antiproliferation of HCC, is the first approved target therapy for HCC.
Zoledronic acid is used for treatment of bone metastasis of diverse malignant cancer. Emerging data suggest that zoledronic acid may also exhibit anticancer properties.
The objectives of the study is to evaluate the safety of Sorafenib combined with Zoledronic Acid and to evaluate overall survival and time to progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Hepatocellular carcinoma confirmed with pathology or identified with radiological images with typical features
- •patient with unresectable primary hepatocellular carcinoma
- •Child-Pugh Class A or B, score ≤ 7
- •ECOG score 0-2
- •Expected survival time not less than 12 weeks
- •At least one tumor nodule with one uni-dimension of ≥ 1 cm
- •Peripheral platelet of or more than 50×10(9)/L
- •Peripheral hemoglobin of or more than 85g/L
- •Peripheral albumen of or more than 28g/L
- •Total bilirubin ≤3.0mg/dl
- •ALT and AST ≤ 5.0 x the upper limit of normal
- •Serum amylase ≤ 1.5x the upper limit of normal
- •Serum creatinine ≤ 1.5x upper limit of normal
- •PT-INR<2.3 or PT prolong no more than 4s of normal
排除标准
- •Congestive heart failure > NYHA class 2
- •History of active coronary disease( except myocardial infarction more than 6 months ago)
- •Receive anti-arrhythmia treatment(except β-receptor blocker,calcium channel blocker and digoxin)
- •uncontrollable hypertension
- •Active clinically serious infections (> 2 NCI-CTC Version 3.0)
- •History of HIV infection
- •Inclined to hemorrhage or active hemorrhage with 1 month
- •Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in this study
- •Pregnant or breast-feeding.Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to enrolling in this portion of the study
- •Known or suspected allergy to any agent given in association with this trial
- •Concomitant anti-cancer therapy (except immunotherapy and Chinese traditional treatment)
- •Surgical operation within 4 weeks prior to enrolling in this portion of the study
研究组 & 干预措施
Sorafenib and Zoledronic Acid
Experimental
干预措施: Sorafenib and Zoledronic Acid (Drug)
结局指标
主要结局
numbers of adverse events
时间窗: 1 year
to evaluate the toxicity of sorafenib in combination with zoledronic acid
次要结局
- Overall survival (OS), time to progression (TTP)(1 year)
研究者
研究点 (1)
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