A Prospective, Randomized, Double-blind, Placebo Controlled, Parallel-group, International Multicenter Phase III Trial of PI-88 in the Adjuvant Treatment of Subjects With Hepatitis Virus Related HCC After Surgical Resection
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 520
- 试验地点
- 25
- 主要终点
- Disease-Free Survival (DFS)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PI-88
Arm 1
干预措施: PI-88 (Drug)
Placebo
Arm 2
干预措施: Placebo (Other)
结局指标
主要结局
Disease-Free Survival (DFS)
时间窗: End of study
To evaluate the efficacy of daily administration of PI-88 versus placebo for the adjuvant treatment of study subjects as measured by DFS during study period. As the median DFS could not be estimated, the overall 25 th percentile DFS was reported.
次要结局
- Time to Recurrence (TTR)(Time to recurrence (TTR) was defined as the time from randomization to the first time that tumor recurrence was observed or suspected during the study period (3 years).)
- Overall Survival (OS)(Overall survival was defined as the time, in weeks, from randomization to death from any cause during the study period (3 years).)
- Tumor Recurrence Rate (TR Rate)(The cumulative tumor recurrence rate at weeks 5, 53, 101 and 149 was reported here.)