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临床试验/NCT05426811
NCT05426811尚未招募1 期

Regorafenib Plus Raltitrexed as Third-line Treatment in Advanced Colorectal Cancer Patients:An Open-label, Single-arm, Multicenter Phase I/II Study

China Medical University, China0 个研究点目标入组 50 人开始时间: 2022年7月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yunpeng Liu

Director of Department of Medical Oncology

China Medical University, China

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