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

Sponsor
UNICANCER
Study ID
NCT06245356
Phase
PHASE2
Status
Recruiting
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Conditions

  • DPD Deficiency
  • Metastatic Colorectal Cancer
  • Metastatic Gastroesophageal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lonsurf — DRUG
    Trifluridine/tipiracil orally 35 mg/m²/dose (D1-D5 twice daily, D1=D15)
  • Oxaliplatin — DRUG
    Oxaliplatin intravenous injection 85 mg/m² every 2 weeks (D1=D15)
  • Panitumumab — DRUG
    Panitumumab intravenous injection 6 mg/kg (D1=D15)
  • Bevacizumab — DRUG
    Bevacizumab intravenous injection 5 mg/kg (D1=D15)
  • Trastuzumab — DRUG
    Trastuzumab intravenous injection 4 mg/kg (D1=D15)
  • Nivolumab — DRUG
    Nivolumab intravenous injection 240 mg (D1=D15)

Study Details

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

Key Dates

Start date
Mar 21, 2025
Status verified
Dec 2025
Primary completion
Oct 22, 2026
Completion
Oct 21, 2028

Study Design

Enrollment
73 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Colorectal adenocarcinoma
    Trifluridine/tipiracil in association with oxaliplatin with or without: * Panitumumab in RAS wild type tumors * Bevacizumab in RAS wild type of right colon or RAS mutated tumors
  • Other: Gastroesophageal adenocarcinoma
    Trifluridine/tipiracil in association with oxaliplatin with or without: * Trastuzumab in HER2-positive tumors (3+ IHC or 2+/FISH+) * Nivolumab if CPS≥5 and HER2-negative tumors

Primary Outcome Measure

Treatment specific safety [ Time Frame: 1 month ]

Central Contacts

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