Regorafenib Plus Raltitrexed as Third-line Treatment in Advanced Colorectal Cancer Patients:An Open-label, Single-arm, Multicenter Phase I/II Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
This is a multicenter, open, single-arm, phase I/II study to evaluate the efficacy and safety of regorafenib plus raltitrexed as third-line treatment in patients with advanced colorectal cancer.
详细描述
This is a multicenter, open, single-arm, phase I/II study to evaluate the efficacy and safety of regorafenib plus raltitrexed as third-line treatment in patients with advanced colorectal cancer.This Phase Ib/II study consists of two parts, Phase Ib, an open-ended, single-arm, multi-centre, dose-escalation study evaluating regorafenib, and Phase II, an open-label, multi-centre study evaluating the efficacy and safety of regorafenib in combination with raltitrexed.The primary study endpoint: progression-free survival (PFS).The secondary end endpoints include ORR (overall effectiveness of tumour treatment),DCR (disease control rate),3 month/6 month/9 month/12 month survival OS%,OS (overall survival),incidence and severity of adverse events (AEs), serious adverse events (SAEs).
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
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Regorafenib combined with Raltitrexed
Regorafenib:
120mg/d,Po,qd,d1-d21,Every 4 weeks
Raltitrexed:
3mg/㎡,ivgtt,d1,Every 3 weeks
干预措施: Regorafenib (Drug)
Regorafenib combined with Raltitrexed
Regorafenib:
120mg/d,Po,qd,d1-d21,Every 4 weeks
Raltitrexed:
3mg/㎡,ivgtt,d1,Every 3 weeks
干预措施: Raltitrexed (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: one year
PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.
次要结局
- Objective Response Rate (ORR)(one year)
- Disease Control Rate (DCR)(one year)
- Overall Survival (OS)(two years)
- Incidence and severity of adverse events (AE) and serious adverse events (SAE)(two years)
研究者
Yunpeng Liu
Director of Department of Medical Oncology
China Medical University, China
