Status:
NOT_YET_RECRUITING
A Real-world Study of Trifluridine/Tipiracil Containing Regimen for the Treatment of Patients With mCRC (REFLECT Study)
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Brief 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 al...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06195111
Start Date
March 1 2024
End Date
December 31 2027
Last Update
January 8 2024
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