Fruquintinib in Refractory Metastatic Colorectal Cancer: A Real-world Study

Colorectal Cancer Clinical Trial

Official title:

Fruquintinib in Refractory Metastatic Colorectal Cancer: A Real-world Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06202417
• Other study ID #: Fruquintinib real-world
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: December 25, 2023

Study information

• Verified date: January 2024
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Fruquintinib is an oral tyrosine kinase inhibitor (TKI), which improves progression-free survival (PFS) and overall survival (OS) in patients with refractory metastatic colorectal cancer (mCRC). Here, we explore the real-world treatment patterns of fruquintinib in the third- or late-line setting for mCRC in six centers in China.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 520
• Est. completion date: December 25, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Metastatic Colorectal Cancer
• Refractory Colorectal Cancer

Intervention

Drug:
• Fruquintinib
an oral tyrosine kinase inhibitor (TKI)

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	PFS was calculated from the date of fruquintinib administration to the first observation of disease progression or death	Three years
Primary	OS	OS was defined as the time from fruquintinib administration to death	Three years
Primary	DCR	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