Real-World Effectiveness of Regorafenib in the Treatment of Patients With Metastatic Colorectal Cancer
1 other identifier
observational
300
1 country
1
Brief Summary
Real-World Effectiveness of Regorafenib in the Treatment of Patients with Metastatic Colorectal Cancer- A Retrospective, Observational Study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 20, 2021
CompletedFirst Submitted
Initial submission to the registry
July 29, 2021
CompletedFirst Posted
Study publicly available on registry
August 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2022
CompletedApril 1, 2022
March 1, 2022
1.4 years
July 29, 2021
March 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (1)
Survival differences among the patients with different clinical phenotypes and genotypes
2021.7-2022.10
Study Arms (2)
Regorafenib group
Patients were given only regorafenib orally
Joint group
The patient was treated with regorafenib orally and in combination with other medications
Interventions
Eligibility Criteria
Patients with pathologically proven colorectal adenocarcinoma whose disease progressed after two lines of antitumor therapy were treated with regorafenib alone or in combination.
You may qualify if:
- Must be a pathologically proven colorectal adenocarcinoma
- Must have been treated with regorafenib
- Regorafenib must be used after two lines of standard antitumor therapy
You may not qualify if:
- Application is less than one course of treatment with regorafenib
- First - or second-line treatment with regorafenib
- Patients with multiple primary cancers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Henan cancer hosiptal
Zhengzhou, Henan, 450008, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shujun Yang
Henan Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
July 29, 2021
First Posted
August 26, 2021
Study Start
July 20, 2021
Primary Completion
December 21, 2022
Study Completion
December 21, 2022
Last Updated
April 1, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- At any time
- Access Criteria
- Research needs
Clinical data of the patients