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

NCT ID: NCT06195111

Last Updated: 2024-01-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2027-12-31

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 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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Trifluridine/Tipiracil

Intervention Type: DRUG

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

Interventions

Trifluridine/Tipiracil

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

Intervention Type: DRUG

Other Intervention Names

TAS-102; FTD/TPI; Lonsurf

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Ying Yuan, ph.D & MD

Role: CONTACT

yuanying1999@zju.edu.cn

+86-13858193601

Dan Li, ph.D & MD

Role: CONTACT

li_dan@zju.edu.cn

+86-15868405387

Other Identifiers

2023-0994

Identifier Type: -

Identifier Source: org_study_id