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Colorectal CancerPhase 2FRUITIONNCT06992258

A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/Metastatic Colorectal Cancer

A Phase 2 study testing Fruquintinib+ Lonsurf (trifluridine and tipiracil) and Fruquintinib in people with Colorectal Cancer, run by Criterium, Inc. at 13 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients with Refractory Advanced/Metastatic Microsatellite Stable Colorectal Cancer Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
Fruquintinib+ Lonsurf (trifluridine and tipiracil) and Fruquintinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
13 sitesUnited States
Study dates
27 Oct 2025to 31 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Patients with known MSI-high or mismatch repair deficient (dMMR) status or in whom the status of both are unknown
  • Patients with BRAF V600 mutations
  • Prior treatment with regorafenib, trifluridine-tipiracil (TAS-102), or fruquintinib.
  • Major surgery within 14 days of C1D1. Minor procedures (e.g. biopsies, central venous catheters) are not considered major surgery.
  • Patients must have recovered from clinically significant AEs of their most recent prior therapy/intervention prior to enrollment as determined by relevant clinical and laboratory parameters.
  • Untreated CNS metastases or known leptomeningeal disease. Patients with treated CNS metastases (either by surgical or radiation techniques) are eligible provided there is no evidence of progression for at least 4 weeks after CNS-directed therapy as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period.
Show all 30Show fewer
  • Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessments of the investigational regimen. Patients whose prior or concurrent malignancy natural history and/or treatment does NOT have the potential to impact safety or study assessments are eligible.
  • Uncontrolled intercurrent illness (defined as but not limited to others in the opinion of the treating investigator):
  • Uncontrolled pleural effusion, pericardial effusion or ascites defined as requiring recurrent drainage procedures within 3 weeks of C1D1
  • Uncontrolled arrhythmia or any ventricular arrhythmia requiring treatment
  • Uncontrolled hypertension (≥ 160 mmHg systolic or ≥ 100mmHg diastolic in spite of maximal medical therapy)
  • Urine dipstick or urinalysis with protein ≥ 2+ or 24-hour urine protein ≥ 1.0g/24 hours. Patients with 1+ proteinuria must undergo a urine protein creatinine ratio (UPCR) or 24-hour urine collection to assess protein level. For interpretation of lab values for proteinuria please see Appendix E.
  • New York Heart Association (NYHA) Functional Classification class 3 or 4 congestive heart failure or left ventricular ejection fraction < 50%
  • Severe or unstable angina within 3 months prior to C1D1
  • Active infection requiring IV antibiotics within 1 week prior to C1D1. Antibiotics used for prophylactic purposes are allowed.
  • Corrected QT interval using the Fridericia method > 470 msec (repeated demonstration of the QTcF interval if > 470 msec during first assessment) or any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as congenital long QT syndrome or family history of long QT syndrome
  • History of or active gastric/duodenal ulcer or ulcerative colitis, active hemorrhage of an unresected gastrointestinal tumor, history of obstruction, perforation or fistulas, and any other condition that could, in the investigator's judgment, result in significant gastrointestinal hemorrhage or perforation, within 6 months prior to C1D1.
  • History or presence of hemorrhage from any other site (e.g. hemoptysis or hematemesis) within 3 months prior to C1D1.
  • History of a venous thromboembolic event (e.g. deep vein thrombosis or pulmonary embolism) within 3 months prior to C1D1.
  • History of an arterial thromboembolic event (e.g. stroke/CVA, transient ischemic event, unstable angina, acute myocardial infarction/coronary artery bypass surgery) within 6 months prior to C1D1.
  • Tumor invasion of a large vascular structure (e.g. pulmonary artery, superior or inferior vena cava).
  • Inability to discontinue medications with a known risk of causing QT prolongation and/or torsades de pointes within 7 days of C1D1.
  • Use of strong or moderate inducers of CYP3A within 7 days of C1D1.
  • Patients with AIDS. HIV-infected patients on effective anti-retroviral therapy with an undetectable viral load during the screening period are eligible.
  • For patients with known chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy during the screening period. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load during the screening period.
  • Recent COVID-19 diagnosis (symptomatic or asymptomatic). To become eligible (following symptomatic infection), the patient must not have fever for 24 hours (without using medicine to reduce fever), other symptoms have improved, and at least 10 days have passed since onset of symptoms. To become eligible (following asymptomatic infection, e.g. positive test only), at least 10 days have passed since the positive test. In either case, a repeat COVID-19 test is not required. Likewise, a persistently positive test (if obtained) does not continue to exclude the patient should the other criteria be satisfied.
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to any of the study medications or their classes
  • Inability to swallow, retain and/or absorb oral medications
  • Pregnant or lactating or intending to become pregnant during the study interval
  • Other uncontrolled serious medical or psychiatric illness that would impact study participation and/or follow up in the opinion of the treating investigator

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Soumaya Chappidi contact

518-828-1274

FRUQ004PM@criteriuminc.com

Julee Hartwell contact

518-828-1274

FRUQ004PM@criteriuminc.com

13 sites in 1 country

United States13 sites, 13 recruiting

  • Medical University of South Carolina / MUSC

    Charleston, South Carolina, 29407

    Site Public Contact Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu

    Recruiting

  • Inova Schar Cancer

    Fairfax, Virginia, 22031

    Stephanie Van Bebber, 571-472-0213, stephanie.vanbebber@inova.org

    Recruiting

  • UPenn Lancaster-Ann B. Barshinger Cancer Institute

    Lancaster, Pennsylvania, 17601

    Krista Budzik, 717-544-0511, Krista.Budzik@pennmedicine.upenn.edu

    Recruiting

  • Mount Sinai Cancer Research Program

    Miami Beach, Florida, 33140

    Yvonne Enriquez Nunez, 305-674-2625, Yvonne.Enriquez@msmc.com

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Kristen Ciombor, MD, 800-811-8480, cip@vumc.org

    Recruiting

  • Rutgers Cancer Institute

    New Brunswick, New Jersey, 08903

    Kassie Diorio, kassie.diorio@rutgers.edu

    Recruiting

  • Yale University

    New Haven, Connecticut, 06520

    Melissa George, 475-331-2949, melissa.george@yale.edu

    Recruiting

  • NYU Langone Health

    New York, New York, 10016

    Mark Bond, 212-404-3748, mark.bond@nyulangone.org

    Jennifer Coffey, Jennifer.coffey@nyulangone.org

    Recruiting

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

    Janice Porter, 321-841-7246, janice.porter@orlandohealth.com

    Recruiting

  • Thomas Jefferson University - Sidney Kimmel Comprehensive Cancer Center

    Philadelphia, Pennsylvania, 19107

    Elizabeth Gudesblat, 215-520-1577, elizabeth.gudesblat@jefferson.edu

    Recruiting

  • UPMC / University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

    Debra Diecks, 412-623-8364, diecksda@upmc.edu

    Recruiting

  • Mays Cancer Center at University of Texas Health at San Antonio

    San Antonio, Texas, 78229

    Jennifer Moseley, 210-450-1799, moseleyj@uthscsa.edu

    Recruiting

  • Swedish Cancer Institute

    Seattle, Washington, 98104

    Sidney Ching, 206-386-3142, sidney.ching@swedish.org

    Recruiting

Other trials in United States

About this study

A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients with Refractory Advanced/Metastatic Microsatellite Stable Colorectal Cancer

Being tested
Fruquintinib+ Lonsurf (trifluridine and tipiracil), 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.

  • Fruquintinib+ Lonsurf (trifluridine and tipiracil)Drug

    Experimental arm

  • FruquintinibDrug

    Standard Of Care Arm

Study groups in NCT06992258
Study groupRoleWhat they receive
Fruquintinib and LonsurfExperimentalNot described
Receives: Drug: Fruquintinib+ Lonsurf (trifluridine and tipiracil)
FruquintinibActive comparatorNot described
Receives: Drug: Fruquintinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To estimate the progression-free survival (PFS) benefit of fruquintinib in combination with TAS-102 as compared to fruquintinib

    Progression free survival (PFS) defined as time from randomization to first observation of progression using RECIST v1.1 or death from any cause.

    Measured: 24 months

Secondary outcomes (5)

  1. Estimate the confirmed objective response rate (ORR) of fruquintinib in combination with TAS-102 as compared to fruquintinib

    Objective response rate (ORR) defined as partial response or complete response using RECIST v1.1

    Measured: 24 months

  2. Estimate the disease control rate (DCR) of fruquintinib in combination with TAS-102 as compared to fruquintinib

    Disease control rate (DCR) defined as partial response, complete response, or stable disease using RECIST v1.1

    Measured: 24 months

  3. Estimate the clinical benefit rate (CBR) of fruquintinib in combination with TAS-102 as compared to fruquintinib

    Clinical benefit rate (CBR defined as the percentage of patients achieving a partial response, complete response, or stable disease for at least 6 months using RECIST v1.1

    Measured: 24 months

  4. Estimate the overall survival (OS) of fruquintinib in combination with TAS-102 as compared to fruquintinib

    Overall survival (OS) defined as time from randomization to death from any cause

    Measured: 24 months

  5. Characterize the toxicity profile of fruquintinib in combination with TAS-102

    Toxicity profile comprised of: Incidence of grade 3 or more treatment-related adverse events (TRAE), Percent of patients requiring dose reductions or dose delays due to TRAE, Percent of patients requiring treatment discontinuation due to TRAE

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2025
  2. Study start27 Oct 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Study
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06992258
Sponsor's protocol ID
CCR-AGICC-Fruq-004
Acronym
FRUITION
Status last verified
Aug 2026
First submitted
30 Apr 2025
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fruquintinib+ Lonsurf (trifluridine and tipiracil) and Fruquintinib in people with Colorectal Cancer, run by Criterium, Inc. at 13 sites in United States.

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 0 inclusion and 30 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Soumaya Chappidi (518-828-1274, FRUQ004PM@criteriuminc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To estimate the progression-free survival (PFS) benefit of fruquintinib in combination with TAS-102 as compared to fruquintinib (time frame: 24 months). 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 NCT06992258.

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 15 Oct 2026.

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