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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

74

Participants

Timeline

Start Date

December 31, 2025

Primary Completion Date

February 28, 2028

Study Completion Date

October 31, 2028

Conditions
Metastatic Colorectal Carcinoma (mCRC)
Interventions
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

Trial Locations (45)

Unknown

ICO Site Paul Papin, Angers

Les Bonnettes, Arras

Ght Unyon Auxerre, Auxerre

Bayeux Ch, Bayeux

Cote Basque, Bayonne

Beauvais Ch, Beauvais

Jean Minjoz, Besançon

Centre Pierre Curie, Beuvry

BERGONIÉ, Bordeaux

TIVOLI, Bordeaux

Chauny Ch, Chauny

Cholet Ch, Cholet

Saint Côme, Compiègne

Clinique de Flandre, Coudekerque-Branche

GHPSO Site de Creil, Creil

Centre Leonard de Vinci, Dechy

Dijon Bourgogne, Dijon

Institut de cancérologie de Bourgogne GRReCC, Dijon

CHD Vendée, La Roche-sur-Yon

Docteur Schaffner, Lens

Franco Britannique, Levallois-Perret

Jean Mermoz, Lyon

La Timone, Marseille

LAYNÉ CH, Mont-de-Marsan

Centre de Cancérologie du Grand Montpellier, Montpellier

Confluent Sas, Nantes

Groupe Hospitalier Diaconesses Croix Saint Simon, Paris

Hôpital Européen G Pompidou, Paris

La Pitié Salpêtrière, Paris

Saint Louis, Paris

La Miletrie, Poitiers

Jean Godinot, Reims

Robert Debré, Reims

Saint Gregoire Chp, Saint-Grégoire

ICO Site René Gauducheau, Saint-Herblain

Clinique Mutualiste de L'Estuaire, Saint-Nazaire

Hopital Nord Chu Saint Etienne, Saint-Priest-en-Jarez

Saint Malo Ch, St-Malo

ICAN Institut de Cancérologie de Strasbourg Europe, Strasbourg

Sainte Anne, Strasbourg

LEMAN, Thonon-les-Bains

Valence Ch, Valence

BRABOIS, Vandœuvre-lès-Nancy

Ch Nord Ouest, Villefranche-sur-Saône

Gustave Roussy, Villejuif

All Listed Sponsors
lead

Federation Francophone de Cancerologie Digestive

OTHER