Colorectal CancerNCT06202417
Fruquintinib in Refractory Metastatic Colorectal Cancer: A Real-world Study
An observational study of Colorectal Cancer and Refractory Colorectal Cancer, run by Fudan University at 1 site in China.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer, Refractory Colorectal Cancer, Metastatic Colorectal Cancer
- What is being tested?
- Fruquintinib
- Type of treatment
- Pill or oral medicine
- How many people
- 520 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 25 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with refractory mCRC and administered fruquintinib from January 1, 2021 to June 31, 2022
Who may be able to join
- 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.
Who cannot join
- lack of follow-up data; (2) fruquintinib administration as second-line treatment; (3) fruquintinib administration stopped after less than two cycles.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
About this 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.
- Being tested
- Fruquintinib
- Keywords
- Fruquintinib
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FruquintinibDrug
Also called PD1 antibodies, chemotherapy drugs
an oral tyrosine kinase inhibitor (TKI)
| Study group | Role | What they receive |
|---|---|---|
| monotherapy group | patients received fruquintinib alone Receives: Drug: Fruquintinib | |
| combine group | patients administered fruquintinib in combination with chemotherapy or/and anti-PD1 antibodies Receives: Drug: Fruquintinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
PFS was calculated from the date of fruquintinib administration to the first observation of disease progression or death
Measured: Three years
OS
OS was defined as the time from fruquintinib administration to death
Measured: 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
Measured: During the medication period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 Jan 2021
- Primary completion30 Jun 2022
- Study completion25 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu jianmin, Fudan University
- Investigators
- Jianmin Xu, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202417
- Sponsor's protocol ID
- Fruquintinib real-world
- Status last verified
- Jan 2024
- First submitted
- 1 Jan 2024
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Contact PI of the study for IPD when publication is online
Publications
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.
PubMed 39395266
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fruquintinib in Refractory Metastatic Colorectal Cancer: A Real-world Study
- ClinicalTrials.gov ID
- NCT06202417
- Acronym / sponsor ID
- Fruquintinib real-world
- Keywords
- Fruquintinib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 25 Dec 2023 (actual)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| monotherapy group | – | Drug: Fruquintinibpatients received fruquintinib alone |
| combine group | – | Drug: Fruquintinibpatients administered fruquintinib in combination with chemotherapy or/and anti-PD1 antibodies |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with refractory mCRC and administered fruquintinib from January 1, 2021 to June 31, 2022
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- lack of follow-up data; (2) fruquintinib administration as second-line treatment; (3) fruquintinib administration stopped after less than two cycles.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FruquintinibAlso: PD1 antibodies, chemotherapy drugsan oral tyrosine kinase inhibitor (TKI) | Drug | combine group, monotherapy group |
Primary outcome
PFS
Time frame: Three years
PFS was calculated from the date of fruquintinib administration to the first observation of disease progression or death
OS
Time frame: Three years
OS was defined as the time from fruquintinib administration to death
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Derived from this study: PubMed 39395266Xu 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.
- Individual participant dataSharing planned: No. Contact PI of the study for IPD when publication is online
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianmin Xu principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Refractory Colorectal Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: Three years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06202417, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.