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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trifluridine/Tipiracil | Drug | This a rospective observational study. There is no treatment allocation. Patients administered Trifluridine/Tipiracil by prescription |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS (Progression-free survival) | 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. | Approximately 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| OS (Overall Survival) | Overall survival defined as the observed time elapsed between the date of first treatment and the date of death due to any cause. | Approximately 12 months |
| ORR(Objective response rate) |
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Inclusion Criteria:
Patients eligible for inclusion in this study have to fulfill all of the following criteria at enrollment:
Exclusion Criteria:
Patients fulfilling any of the following criteria at enrollment are not eligible for inclusion in this study:
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Patients, being treated for mCRC with Trifluridine/Tipiracil-containing regimen.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Yuan, ph.D & MD | Contact | +86-13858193601 | yuanying1999@zju.edu.cn | |
| Dan Li, ph.D & MD | Contact | +86-15868405387 | li_dan@zju.edu.cn |
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|
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.
| Approximately 12 months |
| DCR (Disease control rate) | 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. | Approximately 12 months |
| Quality of life: EORTC QLQ-C30 | Assess patients health and activities using the European Organization for Research and Treatment of Cancer Core Quality of Life (EORTC QLQ-C30) module. | Approximately 12 months |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| C000613803 | trifluridine tipiracil drug combination |
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