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Real-World Effectiveness of Regorafenib in the Treatment of Patients with Metastatic Colorectal Cancer- A Retrospective, Observational Study
To analyze the real-world usage pattern, effectiveness and factors associated with the effectiveness of regorafenib in the treatment of patients with metastatic colorectal cancer (mCRC). This retrospective, observational study included clinicopathological and follow-up data of patients with mCRC who were treated with regorafenib from June 2017 to September 2020. Patients with incomplete data were excluded. Overall survival (OS) stratified by combination therapy with programmed cell death ligand-1 (PD-L1) inhibitors, chemotherapy and regorafenib dose was calculated by Kaplan Meier method and log rank test. R software version 4.0 was used for the analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regorafenib group | Patients were given only regorafenib orally |
| |
| Joint group | The patient was treated with regorafenib orally and in combination with other medications |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nonintervention | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| The difference in overall survival between the two groups calculated by Kaplan-Meier | Survival differences between the monotherapy and combination groups | 2021.7-2022.12 |
| The difference of OS in patients receiving different doses of regorafenib | In the real world, regorafenib was used in different dosages: 40mg,80mg,120mg,160mg,respectively. The difference in overall survival time of patients with different dosage was compared. | 2021.11-2022.12 |
| Regorafenib in combination with other drugs | In the real world, regorafenib was used in combination with chemotherapy, immunotherapy or other drugs, and the frequency of occurrence of different conditions was analyzed. | 2021.7-2022.10 |
| Measure | Description | Time Frame |
|---|---|---|
| Survival differences among the patients with different clinical phenotypes and genotypes | To compare the survival of patients with mCRC by gender, age, tumor site and other genotypes | 2021.7-2022.10 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with pathologically proven colorectal adenocarcinoma whose disease progressed after two lines of antitumor therapy were treated with regorafenib alone or in combination.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shujun Yang, bachelor | Contact | 13803869419 | nkyang@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Shujun Yang | Henan Cancer Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan cancer hosiptal | Recruiting | Zhengzhou | Henan | 450008 | China |
Clinical data of the patients
At any time
Research needs
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |