Colorectal CancerNCT06221423
Fruquintinib Combined With TAS-102 in Refractory Metastatic Colorectal Cancer
An observational study of Colorectal Cancer and Metastatic Colorectal Cancer, run by Fudan University at 1 site in China.
Trial summary
Fruquintinib, as a standard treatment for refractory metastatic colorectal cancer (mCRC), has attracted increasing research efforts to explore its innovative strategies in combination with immunotherapy and chemotherapy because of its multi-target mechanism which enhances the sensitivity of the immune system and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer, Metastatic Colorectal Cancer, Refractory Colorectal Carcinoma
- What is being tested?
- Fruquintinib Combined With TAS-102
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 May 2024
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with refractory metastatic colorectal cancer who have undergone third-line or later treatment with a combination of fruquintinib and TAS-102.
Who may be able to join
- Histology-confirmed metastatic CRC (mCRC)
- 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
- Fruquintinib administered as salvage treatment
- Age: 18-75 years old
- Informed consent
Who cannot join
- Liver or kidney dysfunction, or other conditions unsuitable for chemotherapy
- Fruquintinib and/or TAS-102 administration as second-line treatment
- Drug 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
Official title: A Single-center, Prospective Cohort Study of Fruquintinib Combined With TAS-102 in Refractory Metastatic Colorectal Cancer
Fruquintinib, as a standard treatment for refractory metastatic colorectal cancer (mCRC), has attracted increasing research efforts to explore its innovative strategies in combination with immunotherapy and chemotherapy because of its multi-target mechanism which enhances the sensitivity of the immune system and chemotherapy, aiming to further improve the survival benefits for mCRC patients. Trifluridine/tipiracil (TAS-102) is also a standard treatment for mCRC. This study aims to investigate the safety and effectiveness of the combined use of these two drugs in mCRC.
- Being tested
- Fruquintinib Combined With TAS-102
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruquintinib Combined With TAS-102Drug
Fruquintinib Combined With TAS-102
| Study group | Role | What they receive |
|---|---|---|
| Fru plus TAS-102 | mCRC patients receiveing Fruquintinib combined with TAS-102 in third- or late- line Receives: Drug: Fruquintinib Combined With TAS-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
PFS was calculated from the date of fruquintinib administration to the first observation of disease progression or death.
Measured: 3 years
Overall Survival (OS)
OS was defined as the time from fruquintinib administration to death.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Jan 2020 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Why it stopped: The study was withdrawn before participant enrollment because the research team decided not to initiate the study after reassessing its feasibility.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 0 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, Department of Colorectal Surgery, Zhongshan Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221423
- Sponsor's protocol ID
- Fru plus TAS-102 in mCRC
- Status last verified
- Jul 2026
- First submitted
- 27 Dec 2023
- Last updated
- 3 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Prospective Cohort Study of Fruquintinib Combined With TAS-102 in Refractory Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06221423
- Acronym / sponsor ID
- Fru plus TAS-102 in mCRC
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn before participant enrollment because the research team decided not to initiate the study after reassessing its feasibility.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 24 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, as a standard treatment for refractory metastatic colorectal cancer (mCRC), has attracted increasing research efforts to explore its innovative strategies in combination with immunotherapy and chemotherapy because of its multi-target mechanism which enhances the sensitivity of the immune system and chemotherapy, aiming to further improve the survival benefits for mCRC patients. Trifluridine/tipiracil (TAS-102) is also a standard treatment for mCRC. This study aims to investigate the safety and effectiveness of the combined use of these two drugs in mCRC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fru plus TAS-102 | – | Drug: Fruquintinib Combined With TAS-102mCRC patients receiveing Fruquintinib combined with TAS-102 in third- or late- line |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with refractory metastatic colorectal cancer who have undergone third-line or later treatment with a combination of fruquintinib and TAS-102.
Key inclusion criteria (5 listed)
- Histology-confirmed metastatic CRC (mCRC)
- 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
- Fruquintinib administered as salvage treatment
- Age: 18-75 years old
- Informed consent
Key exclusion criteria (3 listed)
- Liver or kidney dysfunction, or other conditions unsuitable for chemotherapy
- Fruquintinib and/or TAS-102 administration as second-line treatment
- Drug 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 |
|---|---|---|
| Fruquintinib Combined With TAS-102Fruquintinib Combined With TAS-102 | Drug | Fru plus TAS-102 |
Primary outcome
Progression-free Survival (PFS)
Time frame: 3 years
PFS was calculated from the date of fruquintinib administration to the first observation of disease progression or death.
Overall Survival (OS)
Time frame: 3 years
OS was defined as the time from fruquintinib administration to death.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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
Department of Colorectal Surgery, Zhongshan Hospital, 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 Metastatic 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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 3 Aug 2026. 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 was withdrawn before enrolling participants, so there are no results.
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?
Progression-free Survival (PFS) (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.