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

NCT06245356 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2025-12-10

No results posted yet for this study

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

Conditions

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)

Sponsors & Collaborators

  • Servier

    collaborator INDUSTRY

  • UNICANCER

    lead OTHER

Principal Investigators

  • Emmanuelle SAMALIN, MD · Institut du Cancer de Montepllier

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-21
Primary Completion
2026-10-22
Completion
2028-10-21

Countries

  • France

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06245356 on ClinicalTrials.gov