NCT07150403

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

A Phase II, Open-label, Non-comparative, Randomized Study of Second-line Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Fruquintinib Versus Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Bevacizumab in Metastatic Colorectal Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Federation Francophone de Cancerologie Digestive · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Metastatic Colorectal Carcinoma (mCRC)

Interventions

Type	Name	Description
DRUG	Oxaliplatin intravenous	85 mg/m² IV over 2 hours ; 1 cycle each 15 days
DRUG	5 FU bolus	5 fluorouracil : 400 mg/m² in bolus of 10 minutes (intravenous)
DRUG	Folinic acid	400 mg/m² in intravenous
DRUG	5 FU continuous	2400 mg/m² intravenously over 46 hours
DRUG	Irinotecan	180 mg/m² IV over 1h30
DRUG	FRUQUINTINIB	5 mg capsule, taken orally, once daily for 3 weeks, followed by a 7-day break, then resumed (Day 1= Day 29).
DRUG	BEVACIZUMAB	5 mg/kg over 90 minutes for the 1st course and in case of good tolerance the 2nd course should be administered over 60 minutes. The next courses should be administered in 30 minutes in case of good tolerance during the 2nd course

Timeline

• Start date: 2025-12-31
• Primary completion: 2028-02-28
• Completion: 2028-10-31
• First posted: 2025-09-02
• Last updated: 2025-09-08

Locations

45 sites across 1 country: France