A Single-center，Observational，Ambispective Cohort Study of Regorafenib Versus Fruquintinib in Metastatic Colorectal Cancer Patients Who Have Progressed After at Least Second Lines of Chemotherapies
Overview
- Phase
- N/A
- Intervention
- Regorafenib
- Conditions
- Colorectal Cancer
- Sponsor
- Peking University
- Enrollment
- 268
- Locations
- 1
- Primary Endpoint
- Time To Treatment Failure
- Last Updated
- 5 years ago
Overview
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.
Investigators
Shen Lin
MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital
Peking University
Eligibility Criteria
Inclusion Criteria
- •signed and dated informed consent.
- •Diagnosis of histologically confirmed colorectal cancer, stage IV.
- •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.
- •the clinicopathological characteristics and previous therapy were unknown.
- •regorafenib or fruquintinib treatment is less than one cycle in the historical cohort.
Arms & Interventions
Regorafenib
Intervention: Regorafenib
Fruquintinib
Intervention: Fruquintinib
Outcomes
Primary Outcomes
Time To Treatment Failure
Time Frame: 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 Outcomes
- Overall survival(from enrollment of the first subject until the database cut-off approximately 6 months later.)
- Progression-free survival(from enrollment of the first subject until the database cut-off approximately 6 months later.)
- Incidence of adverse events（AEs）(from the first dose to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.)