NCT06195111

A Real-world Study of Trifluridine/Tipiracil Containing Regimen for the Treatment of Patients With mCRC (REFLECT Study)

A Real-world Study of Trifluridine/Tipiracil Containing Regimen for the Treatment of Patients With Metastatic Colorectal Cancer (REFLECT Study)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Trifluridine/Tipiracil	This a rospective observational study. There is no treatment allocation. Patients administered Trifluridine/Tipiracil by prescription

Timeline

• Start date: 2024-03-01
• Primary completion: 2027-03-01
• Completion: 2027-12-31
• First posted: 2024-01-08
• Last updated: 2024-01-08