Safety of Trifluridine/Tipiracil in Patients With Dihydropyrimidine Dehydrogenase Deficiency Diagnosed With Metastatic Colorectal or Gastroesophageal Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

March 21, 2025

Primary Completion Date

October 22, 2026

Study Completion Date

October 21, 2028

Conditions
Metastatic Colorectal CancerMetastatic Gastroesophageal AdenocarcinomaDPD Deficiency
Interventions
DRUG

Lonsurf

Trifluridine/tipiracil orally 35 mg/m²/dose (D1-D5 twice daily, D1=D15)

DRUG

Oxaliplatin

Oxaliplatin intravenous injection 85 mg/m² every 2 weeks (D1=D15)

DRUG

Panitumumab

Panitumumab intravenous injection 6 mg/kg (D1=D15)

DRUG

Bevacizumab

Bevacizumab intravenous injection 5 mg/kg (D1=D15)

DRUG

Trastuzumab

Trastuzumab intravenous injection 4 mg/kg (D1=D15)

DRUG

Nivolumab

Nivolumab intravenous injection 240 mg (D1=D15)

Trial Locations (20)

21079

WITHDRAWN

Centre Georges François Leclerc, Dijon

25000

ACTIVE_NOT_RECRUITING

CHU Jean Minjoz, Besançon

34298

ACTIVE_NOT_RECRUITING

Institut Régional du Cancer de Montpellier - ICM Val d'Aurelle, Montpellier

35403

ACTIVE_NOT_RECRUITING

CH de Saint-Malo, St-Malo

42270

NOT_YET_RECRUITING

CHU Saint-Etienne, Saint-Priest-en-Jarez

49055

NOT_YET_RECRUITING

Institut de Cancérologie de l'Ouest, Angers

49300

ACTIVE_NOT_RECRUITING

Centre Hospitalier de Cholet, Cholet

51092

ACTIVE_NOT_RECRUITING

CHU de REIMS, Reims

51100

RECRUITING

Institut Godinot, Reims

54519

NOT_YET_RECRUITING

Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy

69008

ACTIVE_NOT_RECRUITING

Hôpital Privé Jean Mermoz, Lyon

69495

NOT_YET_RECRUITING

Hospices Civils de Lyon, Pierre-Bénite

75010

ACTIVE_NOT_RECRUITING

Hôpital Saint Louis, Paris

75012

RECRUITING

Hôpital Saint Antoine, Paris

75014

ACTIVE_NOT_RECRUITING

Hôpital Cochin, Paris

75960

ACTIVE_NOT_RECRUITING

Hôpital des Diaconesses Croix Saint Simon, Paris

80054

NOT_YET_RECRUITING

CHU Amiens, Amiens

84918

ACTIVE_NOT_RECRUITING

Institut du Cancer d'Avignon, Avignon

86000

ACTIVE_NOT_RECRUITING

CHU de Poitiers, Poitiers

90400

ACTIVE_NOT_RECRUITING

Hôpital Nord Franche-Comté / Site du Mittan, Trévenans

All Listed Sponsors
collaborator

Servier

INDUSTRY

lead

UNICANCER

OTHER