Real-World Effectiveness of Regorafenib in the Treatment of Patients With Metastatic Colorectal Cancer

Metastatic Colorectal Cancer Clinical Trial

Official title:

Real-World Effectiveness of Regorafenib in the Treatment of Patients With Metastatic Colorectal Cancer-A Retrospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05023720
• Other study ID #: YShujun
• Status: Recruiting
• Start date: July 20, 2021
• Est. completion date: December 21, 2022

Study information

• Verified date: March 2022
• Source: Henan Cancer Hospital
• Contact: Shujun Yang, bachelor
• Phone: 13803869419
• Email: nkyang[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Real-World Effectiveness of Regorafenib in the Treatment of Patients with Metastatic Colorectal Cancer- A Retrospective, Observational Study

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 21, 2022
• Est. primary completion date: December 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

1. Inclusion Criteria:

1. Must be a pathologically proven colorectal adenocarcinoma

2. Must have been treated with regorafenib

3. Regorafenib must be used after two lines of standard antitumor therapy

2. Exclusion Criteria:

1. Application is less than one course of treatment with regorafenib

2. First - or second-line treatment with regorafenib

3. Patients with multiple primary cancers

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Other:
• nonintervention

Locations

Country	Name	City	State
China	Henan cancer hosiptal	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Secondary	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