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Completed

NCT Number: NCT06202417

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Metastatic Colorectal Cancer Neoplasms Neoplasms by Site Rectal Diseases Refractory Colorectal Cancer

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FRUQUINTINIB

Drug

an oral tyrosine kinase inhibitor (TKI)

Other names: PD1 antibodies, chemotherapy drugs

Primary outcomes

  1. PFS

    Time frame: Three years

    PFS was calculated from the date of fruquintinib administration to the first observation of disease progression or death

  2. OS

    Time frame: Three years

    OS was defined as the time from fruquintinib administration to death

  3. 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

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jan 11, 2024
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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