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FRUITFUL Study: Fruquintinib Plus FOLFIRI for Metastatic Colorectal Cancer

This study, called FRUITFUL, is testing a combination of two treatments, fruquintinib and FOLFIRI, for people with metastatic colorectal cancer (cancer that has spread). Fruquintinib works by blocking proteins (VEGFRs) that help tumors grow new blood vessels. You would receive fruquintinib by mouth for 21 days of each 28-day cycle, and FOLFIRI (a chemotherapy combination) intravenously (into a vein) twice per cycle. This study is for patients whose cancer has already been treated with other therapies including oxaliplatin, a fluoropyrimidine, and a BEV-based agent. The main goal is to see how long people live without their cancer growing, and to evaluate the safety of this treatment combination. The study aims to enroll up to 60 participants.

Study design
This is an open-label, single-arm Phase II study, meaning all participants receive the same treatment and both you and your doctors will know which treatment you are getting. Up to 60 participants are planned for enrollment.
What's involved
You would receive oral fruquintinib for 21 days of each 28-day cycle, and FOLFIRI intravenously twice per cycle. Treatment continues until your disease progresses or you experience unacceptable side effects.
Compensation
Not stated in the trial record.
Follow-up
Your progression-free survival will be measured every two cycles (every 56 days) until disease progression or death, for up to two years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07011576

A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL)

Recruiting
PHASE2Ages 18+InterventionalTreatment
SCRI Development Innovations, LLC
~60 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:fruquintinibFOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)

At a glance

Recruiting sites
14 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS) rate at 6 months
Measured over Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days.

Conditions

Colon Cancer
Rectal Cancer
Colorectal Cancer
Colorectal Cancer (CRC)

Explore related trials

Colorectal Carcinoma

Where it's being run

14 sites across 10 states
Texas3
Oregon2
Virginia2
Colorado1
Illinois1
Maryland1
Minnesota1
Missouri1

Study leadership

  • Meredith Pelster, MD · STUDY_CHAIR · SCRI Oncology Partners

Who to contact

Sarah Cannon Sarah Cannon Development Innovations, LLC
[email protected]
844-710-6157
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Confirmed mCRC ; histologically documented adenocarcinoma of the colon or rectum with at least one measurable lesion according to RECIST v1.
Genetic aberrations are allowed, except for microsatellite instability high (MSI-H) and BRAF V600
Participants must have received first-line therapy for mCRC that included oxaliplatin, a fluoropyrimidine, and a BEV-based agent. FOLFOXIRI, BEV, and SOX/BEV regimes are not permitted. A minimum of 2 cycles of first line of therapy must have been completed.
At least 18 years-of-age at the time of signature of the Informed Consent Form (ICF)
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2

Exclusion

Current treatment with other anticancer treatments within 21 days of the first dose of study treatment
Major surgery within 4 weeks of the first planned dose of study treatment
More than one prior systemic treatment for mCRC or any prior systemic treatment including FOLFIRI or irinotecan-based therapy.
Participants who received oxaliplatin and fluoropyrimidine in the first line neoadjuvant or adjuvant setting (prior to Metastatic diagnosis) and progressed within 6 months are not eligible due to lack of BEV exposure.
Uncontrolled, symptomatic brain metastases
Uncontrolled, symptomatic gastrointestinal disease
Participants with uncontrolled hypertension
Women who are pregnant, nursing, or plan to become pregnant while in the study and for at least 6 months after the last administration of study chemotherapy
Men who plan to father a child while in the study and for at least 6 months after the last administration of study chemotherapy
Documented major electrocardiogram (ECG) abnormalities which are clinically significant.
Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment
Presence of other active invasive cancers other than the one treated in this study within 5 years prior to screening

What this trial measures

  • Progression-Free Survival (PFS) rate at 6 monthsEvery 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days.

    Progression-Free Survival (PFS) rate at 6 months, defined as the percentage of participants at 6 months who have not experienced disease progression as defined by the RECIST Version 1.1 criteria or death on study. Participants who are alive and free from disease progression will be censored at the date of last tumor assessment.