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

Completed

• Conditions: Colorectal Cancer; Refractory Colorectal Cancer; Metastatic Colorectal Cancer
• Interventions: Drug: Fruquintinib

• Registration Number: NCT06202417
• Lead Sponsor: Fudan University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-06-30
• Study Completion: 2023-12-25
• Status Verified: 2024-01
• Study First Submitted: 2024-01-01
• Study First Submitted QC: 2024-01-01
• Last Update Submitted: 2024-01-01
• Study First Posted: 2024-01-11
• Last Update Posted: 2024-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 520

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
monotherapy group	Fruquintinib	patients received fruquintinib alone
combine group	Fruquintinib	patients administered fruquintinib in combination with chemotherapy or/and anti-PD1 antibodies

Primary Outcome Measures

Name	Time	Method
OS	Three years	OS was defined as the time from fruquintinib administration to death
PFS	Three years	PFS was calculated from the date of fruquintinib administration to the first observation of disease progression or death
DCR	During the medication period	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

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China