Actively Recruiting
A Phase II Study Investigating Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC)
Led by SCRI Development Innovations, LLC · Updated on 2026-03-18
60
Participants Needed
14
Research Sites
21 weeks
Total Duration
On this page
Sponsors
S
SCRI Development Innovations, LLC
Lead Sponsor
T
Takeda Development Center Americas, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of fruquintinib and FOLFIRI as a second-line treatment for participants with metastatic colorectal cancer (mCRC) who have previously been treated with FOLFOX and Bevacizumab-based first-line therapy. This open-label Phase II study aims to assess the effectiveness and safety of this combination in controlling the disease and improving progression-free survival. Participants will receive fruquintinib orally on days 1 through 21 of each 28-day cycle alongside FOLFIRI given by intravenous infusion every two weeks. The FOLFIRI treatment includes irinotecan, leucovorin, and fluorouracil administered according to standard dosing schedules. Up to 60 participants will be enrolled to receive this combined treatment regimen. During the study, participants will be monitored every two cycles with evaluations including progression-free survival, overall response rate, duration of response, disease control rate, overall survival, and treatment-emergent adverse events. These assessments will continue for up to two years or until disease progression or death. Safety follow-up will extend up to one year after treatment ends, with regular clinical visits and tests to evaluate response and side effects.
CONDITIONS
Brief Title
A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed metastatic colorectal cancer with histologically documented adenocarcinoma of the colon or rectum and at least one measurable lesion
- Genetic aberrations allowed except for microsatellite instability high (MSI-H) and BRAF V600
- Prior treatment with FOLFOX and Bevacizumab-based first-line therapy for mCRC
- At least 18 years old at the time of informed consent
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2
You will not qualify if you...
- Receiving other anticancer treatments within 21 days before starting the study treatment
- Major surgery within 4 weeks before planned study treatment
- More than one prior treatment for metastatic colorectal cancer before signing consent
- Uncontrolled or symptomatic brain metastases
- Uncontrolled, symptomatic gastrointestinal disease
- Uncontrolled hypertension
- Pregnant or nursing women or those planning pregnancy during the study and for 6 months after treatment
- Men planning to father a child during the study and for 6 months after treatment
- Clinically significant major electrocardiogram (ECG) abnormalities
- Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring treatment
- Other active invasive cancers within 5 years prior to screening except the treated cancer in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive oral fruquintinib daily for 21 days and FOLFIRI chemotherapy by intravenous infusion every 2 weeks in repeated 28-day cycles.
Visits every 2 weeks for FOLFIRI infusion and daily oral medication for 21 days each cycle
Duration - Up to 2 years from cycle 1 day 1
Participants are monitored for safety and overall survival after treatment ends, up to 2 years from start of treatment.
Approximately 6 visits over 2 years
Trial Site Locations
Total: 14 locations
1
Rocky Mountain Cancer Center - Primary
Denver, Colorado, United States, 80218
Actively Recruiting
2
Illinois Cancer Specialists
Arlington Heights, Illinois, United States, 60005
Actively Recruiting
3
Maryland Oncology Hematology
Columbia, Maryland, United States, 21044
Actively Recruiting
4
Minnesota Oncology Hematology - Primary
Maple Grove, Minnesota, United States, 55369
Actively Recruiting
5
Missouri Cancer Associates
Columbia, Missouri, United States, 65201
Actively Recruiting
6
Oncology Associates of Oregon - Primary
Eugene, Oregon, United States, 97401
Actively Recruiting
7
Northwest Cancer Specialists - Compass
Portland, Oregon, United States, 97213
Actively Recruiting
8
Alliance Cancer Specialists
Wynnewood, Pennsylvania, United States, 19096
Actively Recruiting
9
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
10
Texas Oncology - Central/South Texas
Austin, Texas, United States, 78705
Actively Recruiting
11
Texas Oncology - Gulf Coast
Beaumont, Texas, United States, 77702
Actively Recruiting
12
Texas Oncology - Northeast Texas
Tyler, Texas, United States, 75702
Actively Recruiting
13
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
14
Blue Ridge Cancer Care (Oncology & Hematology Associates of Southwest VA)
Salem, Virginia, United States, 24153
Actively Recruiting
Research Team
S
Sarah Cannon Sarah Cannon Development Innovations, LLC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here