OncoMatch/Clinical Trials/NCT06475352

Dose Individualization of Chemotherapy in Patients With Gastrointestinal Cancers Lacking a Specific Liver Enzyme

Is NCT06475352 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including FOLFOX regimen and CAPOX regimen for digestive cancer.

Phase 2RecruitingUNICANCERNCT06475352Data as of May 2026

Treatment: FOLFOX regimen · CAPOX regimen — The goal of this clinical trial is to establish guidelines for fluoropyrimidine dose reduction according to uracilemia in patients with DPD deficiency in the treatment of digestive cancers. The main question it aims to answer is: \- Which reduction dose of fluoropyrimidine is needed for patient with DPD deficiency? Participants will: * Take the treatment with the reduction of dose stated by the protocol * Visit the clinic once every 2-3 weeks for checkups and tests for collection of adverse events

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Biomarker criteria

Excluded: DPYD complete DPD deficiency

Patients with complete DPD deficiency based on [U] ≥150 ng/mL

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: fluoropyrimidine (5-FU, capecitabine)

Any prior treatment including a fluoropyrimidine

Lab requirements

Blood counts

adequate bone marrow function (CBC)

Kidney function

estimated glomerular filtration rate (DFG) ≥ 50 ml/min

Liver function

ALP/ASAT/ALAT ≤ 5 ULN, bilirubin ≤ 50 micromol/L

Adequate bone marrow function (CBC), estimated glomerular filtration rate (DFG) ≥ 50 ml/min, ALP/ASAT/ALAT ≤ 5 ULN, and bilirubin ≤ 50 micromol/L

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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