Second-line Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Fruquintinib Versus Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Bevacizumab in Metastatic Colorectal Cancer

The standard second-line treatment for metastatic colorectal cancer (mCRC) involves chemotherapy (FOLFOX or FOLFIRI) combined with an antiangiogenic agent, such as bevacizumab or aflibercept. Maintaining VEGF inhibition between first and second-line treatments has shown modest clinical benefits, with exploratory analyses suggesting that bevacizumab is more effective in smaller tumors. The ULYSSE trial aims to evaluate the efficacy and safety of Fruquintinib, a potent antiangiogenic agent, combined with a doublet chemotherapy (FOLFOX or FOLFIRI) in second-line treatment for BRAF wild-type, MSS mCRC patients who have failed prior treatment.

NCT Number	NCT07150403
Lead Sponsor	Federation Francophone de Cancerologie Digestive
Conditions	Metastatic Colorectal Carcinoma (mCRC)
Enrollment	74 participants
Start Date	2025-12-31
Primary Completion	2028-02-28 (estimated)
Study Completion	2028-10-31 (estimated)
Updated on ClinicalTrials.gov	2025-09-08