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

NCT06202417 | Completed

• 1 other identifier: Fruquintinib real-world
• Study Type: observational
• Target: 520
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Refractory Colorectal Cancer; Metastatic Colorectal Cancer

Keywords

Fruquintinib

Outcome Measures

Primary Outcomes (3)

• PFS

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

  Three years

• OS

  OS was defined as the time from fruquintinib administration to death

  Three years

• 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

Study Arms (2)

monotherapy group

patients received fruquintinib alone

Drug: Fruquintinib

combine group

patients administered fruquintinib in combination with chemotherapy or/and anti-PD1 antibodies

Drug: Fruquintinib

Interventions

Fruquintinib DRUG

an oral tyrosine kinase inhibitor (TKI)

Also known as: PD1 antibodies, chemotherapy drugs

combine group; monotherapy group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• (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.

You may not qualify if:

• (1) lack of follow-up data; (2) fruquintinib administration as second-line treatment; (3) fruquintinib administration stopped after less than two cycles.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

• Xu D, Zeng S, Qiu W, Wang G, Qin Z, Liu Y, Zhou S, Zhang Z, Chang W, Feng Q, Xu J. Fruquintinib in refractory metastatic colorectal cancer: a multicenter real-world study. ESMO Open. 2024 Nov;9(11):103702. doi: 10.1016/j.esmoop.2024.103702. Epub 2024 Oct 11.

  PMID: 39395266 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

HMPL-013; Antineoplastic Agents

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Jianmin Xu

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Colorectal Surgery

Study Record Dates

• First Submitted: January 1, 2024
• First Posted: January 11, 2024
• Study Start: January 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: December 25, 2023
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)