Real World Study of Regorafenib Versus Fruquintinib in Colorectal Cancer
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
1 other identifier
observational
268
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 25, 2020
CompletedFirst Submitted
Initial submission to the registry
June 6, 2020
CompletedFirst Posted
Study publicly available on registry
June 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedJune 16, 2020
June 1, 2020
1.2 years
June 6, 2020
June 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time To Treatment Failure
the time from first dose to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.
every month, up to discontinuation of treatment for any reason.
Secondary Outcomes (3)
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.
Study Arms (2)
Regorafenib
Fruquintinib
Interventions
Eligibility Criteria
Patients with signing the informed consent, would be enrolled when their gastrointestinal physician prescribed to receive regorafenib or fruquintinib after second-line according the condition.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital
Study Record Dates
First Submitted
June 6, 2020
First Posted
June 16, 2020
Study Start
May 25, 2020
Primary Completion
August 1, 2021
Study Completion
February 1, 2022
Last Updated
June 16, 2020
Record last verified: 2020-06