A Randomized Phase III Study of Oxaliplatin (Eloxatin) and Capecitabine on Top of Sorafenib Versus Sorafenib Alone as First-line Palliative Treatment in Advanced Hepatocellular Carcinoma Patients
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Sanofi
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
Primary Objective:
- To evaluate the efficacy of SECOX regimen by adding oxaliplatin plus capecitabine to sorafenib versus sorafenib alone as palliative treatment for unresectable HCC patients to prolong overall survival (OS) for advanced HCC patients.
Secondary Objective:
- To compare the efficacy of SECOX regimen with Sorafenib alone for progression free survival (PFS)
- To compare the efficacy of SECOX regimen with Sorafenib alone for response rate (RR)
- To assess the overall safety profile of SECOX regimen in comparison of Sorafenib alone
详细描述
For each patient, the study consists of a baseline period of screening up to 2 weeks, a treatment period with 2 weeks as one study treatment cycle.
Each patient will be randomly assigned to receive either SECOX (Sorafenib, Oxaliplatin with Capecitabine) or Sorafenib alone every 2 weeks until disease progression, intolerable toxicity, or patient's refusal of further study treatment. There will be a 30-day follow-up visit after the last study treatment.
All patients will be follow-up every 2 months until death is observed during post-treatment follow-up period.
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 75 Years（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
SECOX regimen
Oxaliplatin (Eloxatin) 85mg/m2 , 2 hour infusion, day 1 Capecitabine (Xeloda) 850 mg/m2 BID orally daily, from day 1 to 7 Sorafenib (Nexavar) 400 mg BID orally daily, from day 1 to 14 (continuously)
干预措施: oxaliplatin (SR96669) (Drug)
SECOX regimen
Oxaliplatin (Eloxatin) 85mg/m2 , 2 hour infusion, day 1 Capecitabine (Xeloda) 850 mg/m2 BID orally daily, from day 1 to 7 Sorafenib (Nexavar) 400 mg BID orally daily, from day 1 to 14 (continuously)
干预措施: capecitabine (Drug)
SECOX regimen
Oxaliplatin (Eloxatin) 85mg/m2 , 2 hour infusion, day 1 Capecitabine (Xeloda) 850 mg/m2 BID orally daily, from day 1 to 7 Sorafenib (Nexavar) 400 mg BID orally daily, from day 1 to 14 (continuously)
干预措施: sorafenib (Drug)
Sorafenib alone
Sorafenib (Nexavar) 400 mg BID orally daily, from day 1 to 14 (continuously)
干预措施: sorafenib (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: From the date of randomization to the date of death due to any cause.
defined as the time from randomization to the date of death due to any cause. If death is not observed at the cut off date, data on OS will be censored at the last date when patient is known to be alive or the cut-off date, whichever comes first.
次要结局
- Progression Free Survival (PFS)(From the date of randomization to the date of documentation of progression or death.)
- Response Rate (RR)(From the date of randomization to the end of study.)