OncoMatch/Clinical Trials/NCT06245356
Safety of Trifluridine/Tipiracil in Patients With Dihydropyrimidine Dehydrogenase Deficiency Diagnosed With Metastatic Colorectal or Gastroesophageal Cancer
Is NCT06245356 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for metastatic colorectal cancer.
Treatment: Lonsurf · Oxaliplatin · Panitumumab · Bevacizumab · Trastuzumab · Nivolumab — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Gastric Cancer
Esophageal Carcinoma
Biomarker criteria
Required: DPYD deficiency (plasma uracil concentration ≥16 ng/ml) (plasma uracil concentration ≥16 ng/ml)
known DPD deficiency defined as plasma uracil concentration≥16 ng/ml
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiation therapy
Radiotherapy within 28 days prior to first dose of treatment
Lab requirements
Blood counts
ANC ≥ 1,500/ mm³ without G-CSF; Platelet count ≥100,000/mm³ without platelet transfusion; Hemoglobin ≥9 g/dL without blood transfusion or erythropoietin
Kidney function
Serum creatinine ≤1.5 x ULN; eGFR ≥50 mL/min per 1.73 m² (MDRD formula)
Liver function
Total bilirubin ≤ 1.5 x ULN; ALT and AST ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement); ALP ≤ 2.5 x ULN (≤ 5.0 x ULN for patients with liver involvement and/or bone metastases)
Adequate bone marrow, renal and liver functions as evidenced by the following laboratory requirements within 7 days prior to study treatment initiation
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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