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Safety of Trifluridine/Tipiracil in Patients With Dihydropyrimidine Dehydrogenase Deficiency Diagnosed With Metastatic Colorectal or Gastroesophageal Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT06245356•UNICANCER

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient must have signed and dated a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent.
•2. Histological or cytological documentation of adenocarcinoma of the colon or rectum or gastroesophageal cancer (lower oesophagus, gastroesophageal junction and gastric)
•3. Synchronous or metachronous metastatic colorectal or gastroesophageal cancer
•4. Presence of at least one measurable lesion according to RECIST v1.1
•5. No prior therapy for metastatic disease
•6. known DPD deficiency defined as plasma uracil concentration≥16 ng/ml For plasma uracil concentration \[16-20\[ ng/ml, plasma uracil dosage must be repeated in the 7 days to confirm that plasma uracil concentration ≥16 ng/ml. If the second result is different (i.e; uracil concentration \<16 ng/ml), keep the favourable result, and do not include the patient if only the first plasma uracil concentration≥16 ng/ml.
•7. Age ≥18 years
•8. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
•9. Adequate bone marrow, renal and liver functions as evidenced by the following laboratory requirements within 7 days prior to study treatment initiation:
•1. Absolute neutrophil count (ANC) ≥ 1,500/ mm³ without biologic response modifiers such as granulocyte colony-stimulating factor (G-CSF), within 21 days before the start of study treatment
+12 more criteria

Exclusion Criteria

•1. Previous or concurrent cancer that is distinct in primary site or histology from colorectal or gastroesophageal cancer within 5 years prior to study inclusion, except for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors \[Ta (non invasive tumor), Tis (carcinoma in situ) and T1 (lamina propria invasion)\]
•2. Radiotherapy within 28 days prior to first dose of treatment
•3. Active cardiac disease including any of the following:
•1. Symptomatic Congestive heart failure ≥New York Heart Association (NYHA) class 3 or 4
•2. Severe Unstable angina (angina symptoms at rest)
•3. Myocardial infarction less than 12 months before first dose of treatment
•4. Uncontrolled hypertension (Systolic blood pressure ≥140 mmHg or diastolic pressure ≥ 90 mmHg) despite optimal medical management.
•5. Ongoing infection ≥Grade 2 (NCI CTCAE v.5.0)
•6. Known history of human immunodeficiency virus (HIV) infection
•7. Chronic hepatitis B or C infection (if hepatitis status cannot be obtained from medical records, re-testing is required)
+15 more criteria

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

Key Dates

Start Date

March 21, 2025

Primary Completion Date

October 22, 2026

Completion Date

October 21, 2028

Last Updated

December 10, 2025

Enrollment

ESTIMATED participants

Conditions

Metastatic Colorectal CancerMetastatic Gastroesophageal AdenocarcinomaDPD Deficiency

Interventions

Lonsurf

DRUG

Oxaliplatin

DRUG

Panitumumab

DRUG

Bevacizumab

DRUG

Trastuzumab

DRUG

Nivolumab

DRUG

Contacts

Emilie BRUMENT

CONTACT

+33(0)6 68 32 03 59 e-brument@unicancer.fr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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