A Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group, International, Multicentre Phase III Trial of PI-88 in the Adjuvant Treatment of Post-resection Hepatocellular Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 600
- 主要终点
- Disease-free Survival
研究概览
简要总结
The purpose of this study is to determine if PI-88 is effective and safe in patients who have had surgery to remove primary liver cancer.
详细描述
Primary liver cancer (hepatocellular carcinoma or HCC) is the fifth most common cancer worldwide. Surgery to remove the tumour remains the principal form of treatment for liver cancer, however recurrence of the disease after surgery is common and survival after recurrence is poor. At the moment there is no recommended standard treatment for HCC immediately after the tumour has been removed surgically. PI-88 is a new experimental drug which blocks the growth of new blood vessels in tumours to stop the tumour growing (starves it of food) and also stops tumour cells spreading. Previous experience with PI-88 has shown it has been well tolerated and has shown some benefit in delaying the time it takes for the hepatocellular carcinoma to reappear after surgery. The purpose of this study is to determine if PI-88 is effective and safe in patients who have had surgery to remove primary liver cancer.
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
- 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
- •Histologically-proven primary hepatocellular carcinoma with curative resection performed in the 4 - 6 weeks prior to randomisation.
- •ECOG performance status 0 to 2
- •Child Pugh classification A or B
排除标准
- •Any evidence of tumour metastasis or co-existing malignant disease
- •Any prior recurrence of HCC or any liver resection prior to the most recent procedure
- •History of prior HCC therapy
研究组 & 干预措施
1
干预措施: placebo (Drug)
2
干预措施: PI-88 (Drug)
结局指标
主要结局
Disease-free Survival
时间窗: End of Study
次要结局
- Overall Survival(End of study)
- Time to Recurrence(End of Study)
- Quality of Life(End of Study)
- Safety and Tolerability(End of Study)
- Compliance(End of Study)