OncoMatch/Clinical Trials/NCT05148767
UGT1A1-Based Irinotecan Therapy for Locally Advanced Rectal Cancer
Is NCT05148767 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies Neoadjuvant chemoradiotherapy based on irinotecan for rectal cancer stage iii.
Treatment: Neoadjuvant chemoradiotherapy based on irinotecan — To explore whether the application of irinotecan under the guidance of UGT1A1 gene in neoadjuvant chemotherapy and radiotherapy for locally advanced rectal cancer could improve the clinical efficacy in the real world.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: UGT1A1 any tested
Detection of UGT1A1*6 and *28 gene status.
Excluded: DPYD deficiency
DPD deficiency
Disease stage
Required: Stage N POSITIVE
Clinical stage T3-4 and / or Nude positive, and the treatment plan is nCRT.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Lab requirements
Blood counts
hemoglobin ≥ 90g/L; ANC ≥ 1.5 × 10^9/L
Kidney function
serum creatinine <1x ULN
Liver function
ALT, AST ≤ 2.5x ULN; ALP ≤ 2.5x ULN; serum total bilirubin <1.5x ULN; serum albumin ≥ 30g/L
Cardiac function
No clinically severe (active) heart disease, NYHA class II or higher CHF, severe arrhythmia requiring medication, or MI in last 12 months
Subject blood routine and biochemical indicators do not meet the following criteria: hemoglobin ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; Alanine transaminase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal; alkaline phosphatase (ALP) ≤2.5 times the normal upper limit; serum total bilirubin <1.5 times the normal upper limit; serum creatinine <1 times the normal upper limit; serum albumin ≥ 30g / L. Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention, or a history of myocardial infarction in the last 12 months
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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