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

Sponsor
Henan Cancer Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05023720
Collaborator
(none)
300
Enrollment
1
Location
17.1
Anticipated Duration (Months)
17.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: nonintervention

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 Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Real-World Effectiveness of Regorafenib in the Treatment of Patients With Metastatic Colorectal Cancer-A Retrospective Study
Actual Study Start Date :
Jul 20, 2021
Anticipated Primary Completion Date :
Dec 21, 2022
Anticipated Study Completion Date :
Dec 21, 2022

Arms and Interventions

Arm Intervention/Treatment
Regorafenib group

Patients were given only regorafenib orally

Other: nonintervention
Joint group

The patient was treated with regorafenib orally and in combination with other medications

Other: nonintervention

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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.

  3. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

  1. Inclusion Criteria:

  2. Must be a pathologically proven colorectal adenocarcinoma

  3. Must have been treated with regorafenib

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

  5. Exclusion Criteria:

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

  7. First - or second-line treatment with regorafenib

  8. Patients with multiple primary cancers

Contacts and Locations

Locations

Site City State Country Postal Code
1 Henan cancer hosiptal Zhengzhou Henan China 450008

Sponsors and Collaborators

  • Henan Cancer Hospital

Investigators

  • Study Director: Shujun Yang, Henan Cancer Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shujun Yang, Director, Henan Cancer Hospital
ClinicalTrials.gov Identifier:
NCT05023720
Other Study ID Numbers:
  • YShujun
First Posted:
Aug 26, 2021
Last Update Posted:
Apr 1, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shujun Yang, Director, Henan Cancer Hospital
metastatic colorectal cancer
regorafenib
Additional relevant MeSH terms:
Colorectal Neoplasms

Study Results

No Results Posted as of Apr 1, 2022