A Multinational, Randomized, Open-Label, Phase 3 Study Of Sunitinib Malate Versus Sorafenib In Patients With Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 1,075
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The study will evaluate the efficacy and safety of sunitinib (Arm A), given at 37.5 mg orally once daily, compared to sorafenib (Arm B), given orally at 400 mg twice daily, in patients with inoperable liver cancer. A total number of 1200 patients will be enrolled, 600 on Arm A and 600 on Arm B. Study treatment may be adjusted based on patient tolerance. and will be given until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. After discontinuation of study treatment, patients will be followed up in order to collect information on further antineoplastic therapy and survival.
详细描述
This study was terminated on April 22th, 2010, based on a higher incidence of serious adverse events in the sunitinib arm compared to the sorafenib arm, and the fact that sunitinib did not meet the criteria to demonstrate that it was either superior or non-inferior to sorafenib in the survival of patients with advanced hepatocellular cancer. Patients on sunitinib who are judged by the investigator as receiving clinical benefit may chose to remain on study and continue treatment with sunitinib until clinical benefit as per the investigator's judgment.
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
- None
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-confirmed diagnosis of hepatocellular carcinoma
- •presence of measurable disease by radiographic imaging
- •Child-Pugh class A
- •ECOG PS 0 or 1
- •adequate organ function.
排除标准
- •Prior treatment with any systemic treatment for hepatocellular carcinoma
- •prior local treatment within 4 weeks from entry
- •presence of clinically relevant ascites
- •severe hemorrhage <4 weeks of starting study treatment
- •known HIV or serious acute or chronic illness
- •current treatment on another clinical trial
- •pregnancy or breastfeeding
研究组 & 干预措施
Arm A
sunitinib arm
干预措施: sunitinib malate (Drug)
Arm B
sorafenib arm
干预措施: sorafenib (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150
Overall survival is the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.
次要结局
- Progression-Free Survival (PFS)(Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150)
- Time to Tumor Progression (TTP)(Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150)
- European Quality of Life (EQ-5D)- Health State Profile Utility Score(Day 1 of each cycle)