Real World Study of Regorafenib Versus Fruquintinib in Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04431791
• Other study ID #: Reg vs Fru
• Status: Recruiting
• Start date: May 25, 2020
• Est. completion date: February 1, 2022

Study information

• Verified date: June 2020
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 268
• Est. completion date: February 1, 2022
• Est. primary completion date: August 1, 2021
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. signed and dated informed consent.

2. Diagnosis of histologically confirmed colorectal cancer, stage IV.

3. after second-line therapy.

4. gastrointestinal physician prescribed to receive regorafenib or fruquintinib according the patients' condition.

Exclusion Criteria:

1. received regorafenib or fruquintinib before third-line therapy.

2. the clinicopathological characteristics and previous therapy were unknown.

3. regorafenib or fruquintinib treatment is less than one cycle in the historical cohort.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Regorafenib
oral regorafenib
• Fruquintinib
oral fruquintinib

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival	the time from first dose to the death for any cause.	from enrollment of the first subject until the database cut-off approximately 6 months later.
Secondary	Progression-free survival	the time from first dose to disease progression.	from enrollment of the first subject until the database cut-off approximately 6 months later.
Secondary	Incidence of adverse events(AEs)	percentage of patients with AEs according to CTCAE 4.03	from the first dose to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.