Clinical trial · Observational
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)
NCT06195111CI-TRIAL-00072801not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trifluridine/Tipiracil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Drug: Trifluridine/Tipiracil
Primary outcomes (1)
- measure
- PFS (Progression-free survival)
- timeFrame
- Approximately 12 months
- description
- 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 outcomes (4)
- measure
- OS (Overall Survival)
- timeFrame
- Approximately 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.