RecruitingPhase 2NCT06245356

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

TRIFLUOX-DP: Safety of Trifluridine/Tipiracil as Replacement of Fluoropyrimidines (5-fluorouracil and Capecitabine) Based Chemotherapy as First Line Metastatic Colorectal or Gastroesophageal Cancer Regimens in Patients With Dihydropyrimidine Dehydrogenase Deficiency: a Phase II Trial


Sponsor

UNICANCER

Enrollment

73 participants

Start Date

Mar 21, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to test the safety of the trifluridine/tipiracil as replacement of fluoropyrimidines based chemotherapy as first line metastatic colorectal or gastroesophageal cancer regimens in patients with dihydropyrimidine dehydrogenase (DPD) deficiency. The main questions it aims to answer are: * Is this alternative chemotherapy option a better option in term of safety for this type of patients? * Does the combination of treatments improves the overall safety? * Does the combination of treatments improves the progression-free survival, overall survival, objective response rate and disease control rate? * Does the combination of treatment have an effect on quality of life? Participants will: * Receive the trifluridine/tipiracil with oxaliplatin every 14 days, associated with: * Panitumumab or bevacizumab for colorectal adenocarcinomas * Nivolumab or trastuzumab for gastroesophageal adenocarcinomas. * Have a CT-Scan every 2 months until disease progression * Complete Health-related quality of life questionnaire every 2 months for a maximum of 6 months * Participate to the optional translational research: Blood samples fo DPYD genotyping and pharmacokinetic analysis


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety of trifluridine/tipiracil (also called TAS-102 or Lonsurf) — a chemotherapy used for metastatic colorectal or stomach/esophageal cancer — in a specific group of patients who have a genetic enzyme deficiency called DPD deficiency (dihydropyrimidine dehydrogenase deficiency). DPD normally breaks down certain chemotherapy drugs, and people with this deficiency can have severe reactions to fluorouracil-based drugs. This trial explores whether trifluridine/tipiracil is a safer alternative. **You may be eligible if...** - You have metastatic colorectal cancer or metastatic cancer of the stomach, esophagus, or gastroesophageal junction - You have confirmed DPD deficiency (identified by a specific blood test showing elevated uracil levels) - You have not yet received treatment for your metastatic cancer - You have at least one measurable tumor on imaging scans **You may NOT be eligible if...** - You do not have confirmed DPD deficiency - You have previously received treatment for metastatic disease - You have severe heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLonsurf

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

DRUGOxaliplatin

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

DRUGPanitumumab

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

DRUGBevacizumab

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

DRUGTrastuzumab

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

DRUGNivolumab

Nivolumab intravenous injection 240 mg (D1=D15)


Locations(21)

CHU Amiens

Amiens, France

Institut de Cancérologie de l'Ouest

Angers, France

Institut du Cancer d'Avignon

Avignon, France

CHU Jean Minjoz

Besançon, France

Centre Hospitalier de Cholet

Cholet, France

Centre Georges François Leclerc

Dijon, France

Hôpital Privé Jean Mermoz

Lyon, France

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

Montpellier, France

Hôpital Saint Louis

Paris, France

Hôpital Saint Antoine

Paris, France

Hôpital Cochin

Paris, France

Hôpital des Diaconesses Croix Saint Simon

Paris, France

Hospices Civils de Lyon

Pierre-Bénite, France

CHU de Poitiers

Poitiers, France

CHU de REIMS

Reims, France

Institut Godinot

Reims, France

Institut de Cancérologie de l'Ouest - Site René Gauducheau

Saint-Herblain, France

CHU Saint-Etienne

Saint-Priest-en-Jarez, France

CH de Saint-Malo

St-Malo, France

Hôpital Nord Franche-Comté / Site du Mittan

Trévenans, France

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

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NCT06245356


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