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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05023720
Enrollment
300
Registered
2021-08-26
Start date
2021-07-20
Completion date
2022-12-21
Last updated
2022-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Colorectal Cancer

Keywords

metastatic colorectal cancer, regorafenib

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.

Interventions

Sponsors

Henan Cancer Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
The difference in overall survival between the two groups calculated by Kaplan-Meier2021.7-2022.12Survival differences between the monotherapy and combination groups
The difference of OS in patients receiving different doses of regorafenib2021.11-2022.12In 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 drugs2021.7-2022.10In 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

MeasureTime frameDescription
Survival differences among the patients with different clinical phenotypes and genotypes2021.7-2022.10To compare the survival of patients with mCRC by gender, age, tumor site and other genotypes

Countries

China

Contacts

Primary ContactShujun Yang, bachelor
nkyang@126.com13803869419

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026