118
Participants
Start Date
June 23, 2023
Primary Completion Date
January 31, 2026
Study Completion Date
January 31, 2027
Trifluridine/Tipiracil
Trifluridine/Tipiracil will be administered with a 14-day schedule (35 mg/m² BID for 5 days followed by 9 days of recovery) until disease progression or intolerable toxicity.
Oxaliplatin
Oxaliplatin will be administered intravenously on day 1 of each treatment cycle (infusion duration: 2 hours), every 2 weeks. The first cycle will be administered at level -1 (70 mg/m²) and then increased to 85 mg/m² (if feasible) from the cycle 2 to 8 or until disease progression, whatever occurs first. In case of limiting-oxaliplatin neuropathy and in all cases after 8 cycles, oxaliplatin will be stopped and Trifluridine/Tipiracil will be continued alone until disease progression or intolerable toxicity.
FOLFOX regimen
Folinic Acid 400 mg/m² (or 200 mg/m² if L-folinic acid) + oxaliplatin 85 mg/m² (infusion duration: 2 hours) followed by 5-FU bolus 400 mg/m² and then 5-FU 2400 mg/m² as a 46-hour continuous infusion. Treatment repeated every 14 days. In case of limiting-oxaliplatin neuropathy and in all cases after 8 cycles, oxaliplatin will be stopped and 5-FU (simplified LV5FU2 regimen) or capecitabine (1000 mg/m² BID during 2 weeks every 3 weeks) will be continued alone until disease progression or intolerable toxicity.
Nivolumab
Nivolumab 240 mg (infusion duration 30 minutes, every 2 weeks) until disease progression or intolerable toxicity for a maximum of 2 years
RECRUITING
Hôpital Saint Joseph, Marseille
RECRUITING
Institut Paoli Calmettes, Marseille
WITHDRAWN
Centre Georges François Leclerc, Dijon
RECRUITING
CHU Besançon - Hôpital Jean Minjoz, Besançon
RECRUITING
Hôpital Nord Franche Comté, Montbéliard
RECRUITING
CHU Morvan, Brest
NOT_YET_RECRUITING
Clinique Pasteur Lanroze, Brest
RECRUITING
ICO - Site René Gauducheau, Saint-Herblain
RECRUITING
CH Cholet, Cholet
RECRUITING
CHU - Hôpital Robert Debré, Reims
RECRUITING
Institut Jean Godinot, Reims
RECRUITING
CHU Nancy - Hôpital Brabois, Vandœuvre-lès-Nancy
RECRUITING
Institut Andrée Dutreix - Clinique de Flandre, Coudekerque-Branche
RECRUITING
Centre Hospitalier de Beauvais, Beauvais
RECRUITING
Hopital Privé Arras Les Bonnettes, Arras
RECRUITING
Centre Jean Perrin, Clermont-Ferrand
RECRUITING
CHU d'Estaing, Clermont-Ferrand
RECRUITING
Institut de cancérologie Strasbourg Europe, Strasbourg
RECRUITING
Centre Léon Bérard, Lyon
RECRUITING
Hôpital Nord-Ouest Villefranche-sur-Saône, Gleizé
RECRUITING
Hôpital Saint Louis, Paris
RECRUITING
Hopital Europeen Georges Pompidou, Paris
RECRUITING
GH Diaconesses - Crois St Simon, Paris
RECRUITING
Institut Mutualiste Montsouris, Paris
RECRUITING
CHU Rouen - Charles Nicolle, Rouen
NOT_YET_RECRUITING
Clinique de l'Europe, Amiens
RECRUITING
Institut Sainte Catherine, Avignon
RECRUITING
CHU de Poitiers, Poitiers
RECRUITING
Centre Antoine Lacassagne, Nice
Servier
INDUSTRY
UNICANCER
OTHER