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

Launched by SCRI DEVELOPMENT INNOVATIONS, LLC · Jun 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with metastatic colorectal cancer (mCRC), which is cancer that has spread beyond the colon or rectum. The trial will test the combination of a medication called Fruquintinib with a chemotherapy regimen known as FOLFIRI (which includes leucovorin, fluorouracil, and irinotecan). The main goals are to see how effective this combination is and to understand its safety for patients who have already been treated with other therapies.

To participate in this trial, patients must be at least 18 years old and have a confirmed diagnosis of mCRC. They should have already received specific first-line treatments before joining the study. Certain health conditions, such as uncontrolled high blood pressure or other active cancers, may prevent someone from participating. If eligible, participants can expect regular check-ups and monitoring throughout the trial to assess their response to the treatment and manage any side effects. This study is still in the planning stages and has not yet started recruiting participants.

Gender

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Eligibility 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