Real World Study of Regorafenib Versus Fruquintinib in Colorectal Cancer
Study Details
Study Description
Brief Summary
This is an observational, ambispective cohort study. The aim is to compare the efficacy and safety of regorafenib versus fruquintinib conducted in China. About 268 eligible metastatic colorectal cancer patients after second-line therapy will be assigned to receive either regorafenib or fruquintinib, based on decision of the gastrointestinal physician according the patients' condition.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Regorafenib
|
Drug: Regorafenib
oral regorafenib
|
Fruquintinib
|
Drug: Fruquintinib
oral fruquintinib
|
Outcome Measures
Primary Outcome Measures
- Time To Treatment Failure [every month, up to discontinuation of treatment for any reason.]
the time from first dose to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.
Secondary Outcome Measures
- Overall survival [from enrollment of the first subject until the database cut-off approximately 6 months later.]
the time from first dose to the death for any cause.
- Progression-free survival [from enrollment of the first subject until the database cut-off approximately 6 months later.]
the time from first dose to disease progression.
- Incidence of adverse events(AEs) [from the first dose to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.]
percentage of patients with AEs according to CTCAE 4.03
Eligibility Criteria
Criteria
Inclusion Criteria:
-
signed and dated informed consent.
-
Diagnosis of histologically confirmed colorectal cancer, stage IV.
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after second-line therapy.
-
gastrointestinal physician prescribed to receive regorafenib or fruquintinib according the patients' condition.
Exclusion Criteria:
-
received regorafenib or fruquintinib before third-line therapy.
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the clinicopathological characteristics and previous therapy were unknown.
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regorafenib or fruquintinib treatment is less than one cycle in the historical cohort.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Beijing Cancer Hospital | Beijing | Beijing | China | 100142 |
Sponsors and Collaborators
- Peking University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Reg vs Fru