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

January 1, 2024 updated by: Xu jianmin, Fudan University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

520

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Zhongshan Hospital, Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with refractory mCRC and administered fruquintinib from January 1, 2021 to June 31, 2022

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
monotherapy group
patients received fruquintinib alone
Drug: Fruquintinib
an oral tyrosine kinase inhibitor (TKI)
Other Names:
  • PD1 antibodies
  • chemotherapy drugs
combine group
patients administered fruquintinib in combination with chemotherapy or/and anti-PD1 antibodies
Drug: Fruquintinib
an oral tyrosine kinase inhibitor (TKI)
Other Names:
  • PD1 antibodies
  • chemotherapy drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: Three years
PFS was calculated from the date of fruquintinib administration to the first observation of disease progression or death
Three years
OS
Time Frame: Three years
OS was defined as the time from fruquintinib administration to death
Three years
DCR
Time Frame: 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
During the medication period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Jianmin Xu, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

December 25, 2023

Study Registration Dates

First Submitted

January 1, 2024

First Submitted That Met QC Criteria

January 1, 2024

First Posted (Estimated)

January 11, 2024

Study Record Updates

Last Update Posted (Estimated)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 1, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fruquintinib real-world

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Contact PI of the study for IPD when publication is online

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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