- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06202417
Fruquintinib in Refractory Metastatic Colorectal Cancer: A Real-world Study
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Zhongshan Hospital, Fudan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
(1) histology-confirmed metastatic CRC (mCRC); (2) disease progression on standard therapy with at least two lines of chemotherapy, including fluorouracil, oxaliplatin, and irinotecan with or without biologics such as bevacizumab and cetuximab; (3) fruquintinib administered as salvage treatment; (4) available clinical data.
Exclusion Criteria:
(1) lack of follow-up data; (2) fruquintinib administration as second-line treatment; (3) fruquintinib administration stopped after less than two cycles.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
monotherapy group
patients received fruquintinib alone
|
an oral tyrosine kinase inhibitor (TKI)
Other Names:
|
combine group
patients administered fruquintinib in combination with chemotherapy or/and anti-PD1 antibodies
|
an oral tyrosine kinase inhibitor (TKI)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS
Time Frame: Three years
|
PFS was calculated from the date of fruquintinib administration to the first observation of disease progression or death
|
Three years
|
OS
Time Frame: Three years
|
OS was defined as the time from fruquintinib administration to death
|
Three years
|
DCR
Time Frame: During the medication period
|
DCR was determined as the proportion of patients who achieved complete response, partial response or stable disease assessed at least 6 weeks after drug administration
|
During the medication period
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jianmin Xu, Fudan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Fruquintinib real-world
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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