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临床试验/NCT01259193
NCT01259193Unknown2 期

Phase II Study of Sorafenib and Zoledronic Acid in Advanced HCC

Fudan University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年10月最近更新:
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

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

申办方类型
Other

研究点 (1)

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