A Real-world Study of Trifluridine/Tipiracil Containing Regimen for the Treatment of Patients With mCRC (REFLECT Study)
- Registration Number
- NCT06195111
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- 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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
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.
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Trifluridine/Tipiracil 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.
- Primary Outcome Measures
Name Time Method PFS (Progression-free survival) 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.
- Secondary Outcome Measures
Name Time Method OS (Overall Survival) Approximately 12 months Overall survival defined as the observed time elapsed between the date of first treatment and the date of death due to any cause.
Quality of life: EORTC QLQ-C30 Approximately 12 months Assess patients health and activities using the European Organization for Research and Treatment of Cancer Core Quality of Life (EORTC QLQ-C30) module.
ORR（Objective response rate） Approximately 12 months Objective Response Rate defined as the proportion of patients with objective evidence of complete response (CR) or partial response (PR) according to RECIST version 1.1 criteria and using investigator's tumor assessment.
DCR (Disease control rate) Approximately 12 months Disease control rate defined as the proportion of patients with objective evidence of CR or PR or stable disease (SD) according to RECIST version 1.1 criteria and using investigator's tumor assessment.