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

• Conditions: Metastatic Colorectal Cancer
• Interventions: Other: nonintervention

• Registration Number: NCT05023720
• Lead Sponsor: Henan Cancer Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2021-07-20
• Study First Submitted: 2021-07-29
• Study First Submitted QC: 2021-08-23
• Study First Posted: 2021-08-26
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-20
• Last Update Posted: 2022-04-01
• Primary Completion: 2022-12-21
• Study Completion: 2022-12-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Regorafenib group	nonintervention	Patients were given only regorafenib orally
Joint group	nonintervention	The patient was treated with regorafenib orally and in combination with other medications

Primary Outcome Measures

Name	Time	Method
The difference in overall survival between the two groups calculated by Kaplan-Meier	2021.7-2022.12	Survival differences between the monotherapy and combination groups
The difference of OS in patients receiving different doses of regorafenib	2021.11-2022.12	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.
Regorafenib in combination with other drugs	2021.7-2022.10	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.

Secondary Outcome Measures

Name	Time	Method
Survival differences among the patients with different clinical phenotypes and genotypes	2021.7-2022.10	To compare the survival of patients with mCRC by gender, age, tumor site and other genotypes

Trial Locations

Locations (1)

Henan cancer hosiptal; 🇨🇳 Zhengzhou, Henan, China