NCT00241020已完成3 期
Evaluation of the Efficacy of Long-acting Release Octreotide in Patients With Advanced Hepatocellular Carcinoma
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 270
- 主要终点
- Overall Survival
研究概览
简要总结
Hepatocellular carcinoma (HCC) is one of the most common malignant disease worldwide with an increasing incidence in industrialized countries. For patients with advanced HCC no efficient treatment is currently available. The objective of this study is to assess the efficacy and safety of octreotide in patients with advanced hepatocellular carcinoma.
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
- Triple (Participant, Care Provider, Investigator)
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
- •> 18 years
- •HCC diagnosis :
- •histologically or cytologically proven HCC
- •or association of the three following criteria:
- •cirrhosis
- •typical measurable mass (> 3cm, by 2 methods)
- •serum alpha-foetoprotein (AFP) ≥500 µg/L
- •Cancer Liver Italian Program (CLIP) score : 0 to 3
- •Not eligible for specific treatment (surgery, percutaneous ablation or chemo-embolization)
排除标准
- •Glycemia > 2.5 g/L or hypoglycemia
- •Extra hepatic life-threatening disease
- •Serum creatinin> 120 µmol/L
- •Prothrombin time < 50 %
- •Platelet count < 50.000 /µL
- •Symptomatic cholelithiasis
- •Non-measurable tumor
研究组 & 干预措施
Octreotide
Experimental
干预措施: Octreotide (Drug)
结局指标
主要结局
Overall Survival
次要结局
- Digestive bleeding
- Objective response
- Survival without progression
- Renal insufficiency
- Quality of life
- · Safety
研究者
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