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Fruquintinib plus FOLFIRI for second-line metastatic colorectal cancer

A Phase II Study Investigating Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC)

Phase 2 Interventional SCRI Development Innovations, LLC · NCT07011576

This study will test whether adding fruquintinib to FOLFIRI helps people with metastatic colorectal cancer who progressed after first-line FOLFOX plus bevacizumab.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment60 (estimated)
Ages18 Years and up
SexAll
SponsorSCRI Development Innovations, LLC Academic / other
Drugs / interventionsBevacizumab, chemotherapy, Fruquintinib
Locations14 sites (Denver, Colorado and 13 other locations)
Trial IDNCT07011576 on ClinicalTrials.gov

What this trial studies

This is an open-label, multicenter, single-arm Phase II trial enrolling up to 60 participants to receive fruquintinib together with standard FOLFIRI chemotherapy. Participants must have histologically confirmed metastatic colorectal adenocarcinoma with at least one measurable lesion and prior first-line treatment with FOLFOX plus bevacizumab. The study will give concurrent fruquintinib and FOLFIRI according to standard dosing schedules and monitor tumor response by RECIST and safety outcomes. Primary goals are to see if the combination provides clinical benefit in the second-line setting and to characterize its tolerability.

Who should consider this trial

Good fit: Adults (≥18) with metastatic colorectal adenocarcinoma, measurable disease, ECOG 0–2, who previously received FOLFOX plus bevacizumab and do not have MSI‑H or BRAF V600 mutations.

Not a fit: Patients with MSI‑high or BRAF V600 mutations, uncontrolled symptomatic brain or gastrointestinal disease, uncontrolled hypertension, recent major surgery or other anticancer treatment within the exclusion windows, or more than one prior mCRC treatment are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, the combination could prolong disease control or delay progression for patients needing a second-line option.

How similar studies have performed: VEGFR inhibitors (including bevacizumab) and fruquintinib monotherapy have shown benefit in mCRC, but combining fruquintinib with FOLFIRI as a second-line regimen is relatively new with limited prior data.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key 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 FOLFOX (folinic acid, fluorouracil, and oxaliplatin) and Bevacizumab- based first-line therapy for mCRC
* 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 treatment received for mCRC prior to signing the ICFs
* Uncontrolled, symptomatic brain metastases
* Uncontrolled, symptomatic gastrointestinal disease
* Patients 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 this trial is running

Denver, Colorado and 13 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Colon CancerRectal CancerColorectal CancerColorectal cancerRectal cancerMetastatic colorectal cancermCRCVEGFR inhibitor
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.