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
Sponsor study identifier
Secondary identifiers
CTIS
NIH
interventional
74
1 country
45
Study Start
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
February 28, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 25, 2025
Actual (reported)September 2, 2025
Actual (reported)December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 28, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Disease Control Rate (DCR)
the percentage of patients with a complete response, a partial response or a stable disease at 4 months after the start of treatment.
at 4 months after the start of treatment
FOLFOX (if FOLFIRI in first line) OR FOLFIRI (if FOLFOX in first line); D1 = D15 + FRUQUINTINIB
FOLFOX (if FOLFIRI in first line) OR FOLFIRI (if FOLFOX in first line); D1 = D15 + BEVACIZUMAB (D1 = D15)
85 mg/m² IV over 2 hours ; 1 cycle each 15 days
5 fluorouracil : 400 mg/m² in bolus of 10 minutes (intravenous)
ICO Site Paul Papin
Angers, France
Les Bonnettes
Arras, France
Ght Unyon Auxerre
Auxerre, France
Bayeux Ch
First Submitted
August 25, 2025
First Posted
September 2, 2025
Study Start
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
February 28, 2028
Estimated400 mg/m² in intravenous
2400 mg/m² intravenously over 46 hours
180 mg/m² IV over 1h30
5 mg capsule, taken orally, once daily for 3 weeks, followed by a 7-day break, then resumed (Day 1= Day 29).
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
Contact the study team to confirm eligibility.
Bayeux, France
Cote Basque
Bayonne, France
Beauvais Ch
Beauvais, France
Jean Minjoz
Besançon, France
Centre Pierre Curie
Beuvry, France
BERGONIÉ
Bordeaux, France
TIVOLI
Bordeaux, France
Chauny Ch
Chauny, France
Cholet Ch
Cholet, France
Saint Côme
Compiègne, France
Clinique de Flandre
Coudekerque-Branche, France
GHPSO Site de Creil
Creil, France
Centre Leonard de Vinci
Dechy, France
Dijon Bourgogne
Dijon, France
Institut de cancérologie de Bourgogne GRReCC
Dijon, France
CHD Vendée
La Roche-sur-Yon, France
Docteur Schaffner
Lens, France
Franco Britannique
Levallois-Perret, France
Jean Mermoz
Lyon, France
La Timone
Marseille, France
LAYNÉ CH
Mont-de-Marsan, France
Centre de Cancérologie du Grand Montpellier
Montpellier, France
Confluent Sas
Nantes, France
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, France
Hôpital Européen G Pompidou
Paris, France
La Pitié Salpêtrière
Paris, France
Saint Louis
Paris, France
La Miletrie
Poitiers, France
Jean Godinot
Reims, France
Robert Debré
Reims, France
Saint Gregoire Chp
Saint-Grégoire, France
ICO Site René Gauducheau
Saint-Herblain, France
Clinique Mutualiste de L'Estuaire
Saint-Nazaire, France
Hopital Nord Chu Saint Etienne
Saint-Priest-en-Jarez, France
Saint Malo Ch
St-Malo, France
ICAN Institut de Cancérologie de Strasbourg Europe
Strasbourg, France
Sainte Anne
Strasbourg, France
LEMAN
Thonon-les-Bains, France
Valence Ch
Valence, France
BRABOIS
Vandœuvre-lès-Nancy, France
Ch Nord Ouest
Villefranche-sur-Saône, France
Gustave Roussy
Villejuif, France
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 8, 2025
Record last verified: 2025-09
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Source: ClinicalTrials.gov.
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