A Real-world Study of Trifluridine/Tipiracil Containing Regimen for the Treatment of Patients With Metastatic Colorectal Cancer (REFLECT Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- PFS (Progression-free survival)
研究概览
简要总结
A real-world study of trifluridine/tipiracil containing regimen for the treatment of patients with metastatic colorectal cancer. A total of 200 patients planned to be enrolled.
详细描述
This is a non-randomized, uncontrolled, multicenter real-world study. The total number of subjects is 200. The objective is to observe and evaluate the efficacy and safety of Trifluridine/Tipiracil alone or in combination with other therapies in the treatment of metastatic colorectal cancer in real-world environment. The primary endpoints is Progression-free survival (PFS). Secondary endpoints are overall survival (OS), Objective response rate(ORR), Disease control rate(DCR), progression-free survival (PFS), and Quality of life (QoL).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Patients eligible for inclusion in this study have to fulfill all of the following criteria at enrollment:
- •Male and female patients with ≥18 years of age;
- •Patients with metastatic colorectal cancer confirmed by histopathology;
- •Be willing to use reliable contraceptive methods and refrain from sperm donation throughout the study period and within 3 months after the last dose;
- •Voluntarily join the study and provide written informed consent to participate in the study;
- •Have traceable medical history during the treatment;
- •Doctor believe the patients can benefit from the study.
排除标准
- •Patients fulfilling any of the following criteria at enrollment are not eligible for inclusion in this study:
- •Failure to sign informed consent;
- •Patients with contraindications to Trifluridine/Tipiracil;
- •Female subjects who have a positive pregnancy test or are breastfeeding;
- •Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the study participation.
研究组 & 干预措施
Trifluridine/Tipiracil
Patients with metastatic colorectal cancer plan to recieve Trifluridine/Tipiracil-containing treatment will be enrolled in this study. The prescription all determined by doctor based on patient's situation.
干预措施: Trifluridine/Tipiracil (Drug)
结局指标
主要结局
PFS (Progression-free survival)
时间窗: Approximately 12 months
Progression-free survival defined as the time elapsed between the randomization and the date of radiologic tumour progression according to RECIST version 1.1 by investigator's judgement or death from any cause, whichever comes first.
次要结局
- OS (Overall Survival)(Approximately 12 months)
- Quality of life: EORTC QLQ-C30(Approximately 12 months)
- ORR（Objective response rate）(Approximately 12 months)
- DCR (Disease control rate)(Approximately 12 months)