NCT07011576 · SCRI Development Innovations, LLC
A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC)
(FRUITFUL)
What this study is about
This is an where both patients and doctors know the treatment given conducted at multiple hospitals, single-treatment group$1 Phase II study of Fruquintinib in combination with FOLFIRI (leucovorin calcium (folinic acid), fluorouracil, and irinotecan) in participants with metastatic colorectal cancer (mCRC).
View original scientific description
This is an open-label multicenter, single-arm Phase II study of Fruquintinib in combination with FOLFIRI (leucovorin calcium (folinic acid), fluorouracil, and irinotecan) in participants with metastatic colorectal cancer (mCRC).
Interventions
DRUG
fruquintinib
Participants will receive oral fruquintinib, with or without food, for the first 21 days of each 28-day cycle.
DRUG
FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
Participants will receive FOLFIRI once every 2 weeks on day 1 of every 28-day cycle (twice in each cycle). The FOLFIRI regimen consists of irinotecan given 180 mg/m2 intravenous infusion (IV), leucovorin 400 mg/m2 (or 200 mg/m2 levoleucovorin) IV, followed by 5-fluorouracil (5-FU) 400 mg/m2 bolus injection and 5-FU continuous IV infusion of 2400 mg/m2 over 46 to 48 hours. The 5-FU Bolus may be omitted starting from Cycle 1 Day 1 at the investigators discretion, specifically in participants with a history of cytopenias or toxicities within the first line of treatment.
Primary outcome measures
Progression-Free Survival (PFS) rate at 6 months
Time frame: Every 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 Key
Exclusion criteria
- 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
Where
- Denver, Colorado
- Arlington Heights, Illinois
- Columbia, Maryland
- Maple Grove, Minnesota
- Columbia, Missouri
- Eugene, Oregon
- Portland, Oregon
- Wynnewood, Pennsylvania
- Nashville, Tennessee
- Austin, Texas
- Beaumont, Texas
- Tyler, Texas
And 2 more locations — see the full list below.
Collaborators
Takeda Development Center Americas, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 12, 2026 · Source of record for eligibility and locations