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

Zhejiang University

Status: Not yet enrolling

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: Trifluridine/Tipiracil

Study type: Observational

Funder types: Other

Identifiers

NCT06195111

2023-0994

Details and patient eligibility

About

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.

Full 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).

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.

Trial design

200 participants in 1 patient group

Trifluridine/Tipiracil

Description:

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.

Treatment:

Drug: Trifluridine/Tipiracil