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

Last updated: March 16, 2026
Sponsor: SCRI Development Innovations, LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Colorectal Cancer

Colon Cancer; Rectal Cancer

Rectal Disorders

Treatment

FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)

fruquintinib

Clinical Study ID

NCT07011576
GI 387
  • Ages > 18
  • All Genders

Study Summary

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). The main goals of this study are to:

  • Evaluate the efficacy of the combination of fruquintinib + FOLFIRI in the 2nd-line mCRC setting

  • Evaluate the safety of the combination of fruquintinib + FOLFIRI

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Confirmed mCRC ; histologically documented adenocarcinoma of the colon or rectumwith 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

Exclusion

Key Exclusion Criteria:

  • Current treatment with other anticancer treatments within 21 days of the first doseof 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 andfor 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 afterthe last administration of study chemotherapy

  • Documented major electrocardiogram (ECG) abnormalities which are clinicallysignificant.

  • Symptomatic or uncontrolled brain metastases, spinal cord compression, orleptomeningeal disease requiring concurrent treatment

  • Presence of other active invasive cancers other than the one treated in this studywithin 5 years prior to screening

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
Phase: 2
Study Start date:
September 29, 2025
Estimated Completion Date:
June 30, 2027

Study Description

Fruquintinib is an FDA approved cancer medication that works by targeting proteins called vascular endothelial growth factor receptors (VEGFRs). VEGFRs are important in the creation of new blood vessels. As a highly-selective and potent VEGFR inhibitor, fruquintinib helps block new blood vessels that would provide nutrients and oxygen to cancerous tumors from forming. It is a small molecule anti-tumor drug with a novel chemical structure that belongs to the quinazoline class.

This study is an open-label Phase II study designed to evaluate the efficacy and safety of fruquintinib + FOLFIRI in 2nd-line setting mCRC participants who have been previously treated with FOLFOX (folinic acid, fluorouracil, and oxaliplatin) and Bevacizumab-based first-line therapy. Up to 60 participants will receive concurrent fruquintinib and FOLFIRI according to standard guidelines of treatment of mCRC.

Connect with a study center

  • Rocky Mountain Cancer Center - Primary

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Rocky Mountain Cancer Center - Primary

    Denver 5419384, Colorado 5417618 80218
    United States

    Site Not Available

  • Illinois Cancer Specialists

    Arlington Heights, Illinois 60005
    United States

    Active - Recruiting

  • Maryland Oncology Hematology

    Columbia, Maryland 21044
    United States

    Active - Recruiting

  • Maryland Oncology Hematology

    Columbia 4352053, Maryland 4361885 21044
    United States

    Site Not Available

  • Minnesota Oncology Hematology - Primary

    Maple Grove, Minnesota 55369
    United States

    Active - Recruiting

  • Minnesota Oncology Hematology - Primary

    Maple Grove 5036493, Minnesota 5037779 55369
    United States

    Site Not Available

  • Missouri Cancer Associates

    Columbia, Missouri 65201
    United States

    Active - Recruiting

  • Oncology Associates of Oregon - Primary

    Eugene, Oregon 97401
    United States

    Active - Recruiting

  • Northwest Cancer Specialists - Compass

    Portland, Oregon 97213
    United States

    Active - Recruiting

  • Oncology Associates of Oregon - Primary

    Eugene 5725846, Oregon 5744337 97401
    United States

    Site Not Available

  • Northwest Cancer Specialists - Compass

    Portland 5746545, Oregon 5744337 97213
    United States

    Site Not Available

  • Alliance Cancer Specialists

    Wynnewood, Pennsylvania 19096
    United States

    Active - Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • SCRI Oncology Partners

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

  • Texas Oncology - Central/South Texas

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Texas Oncology - Gulf Coast

    Beaumont, Texas 77702
    United States

    Active - Recruiting

  • Texas Oncology - Northeast Texas

    Tyler, Texas 75702
    United States

    Active - Recruiting

  • Texas Oncology - Central/South Texas

    Austin 4671654, Texas 4736286 78705
    United States

    Site Not Available

  • Texas Oncology - Gulf Coast

    Beaumont 4672989, Texas 4736286 77702
    United States

    Site Not Available

  • Texas Oncology - Northeast Texas

    Tyler 4738214, Texas 4736286 75702
    United States

    Site Not Available

  • Virginia Oncology Associates

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

  • Blue Ridge Cancer Care (Oncology & Hematology Associates of Southwest VA)

    Salem, Virginia 24153
    United States

    Active - Recruiting

  • Virginia Oncology Associates

    Norfolk 4776222, Virginia 6254928 23502
    United States

    Site Not Available

  • Blue Ridge Cancer Care (Oncology & Hematology Associates of Southwest VA)

    Salem 4784112, Virginia 6254928 24153
    United States

    Site Not Available

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