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OncoMatch/Clinical Trials/NCT06210971

Neoadjuvant Chemoradiation With Nal-IRI and Capecitabine Guided by UGT1A1 Status in Patients With Rectal Cancer

Is NCT06210971 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including liposomal irinotecan and Capecitabine for rectal cancer.

Phase 2RecruitingHebei Medical University Fourth HospitalNCT06210971Data as of May 2026

Treatment: liposomal irinotecan · CapecitabineThis single-arm trial will explore the efficacy and safety of long-course neoadjuvant chemoradiation with liposomal irinotecan and capecitabine guided by UGT1A1 status in patients with locally advanced rectal cancer.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Biomarker criteria

Required: UGT1A1 *1*1

UGT1A1 genotype of *1*1

Required: UGT1A1 *1*28

UGT1A1 genotype of *1*28

Disease stage

Required: Stage T3-4NANYM0, T1-2N+M0

Performance status

ECOG 0–1(Restricted strenuous activity)

Lab requirements

Blood counts

ANC ≥1.5×10^9/L, Platelet count ≥100×10^9/L, Hemoglobin (Hb) ≥90 g/L

Kidney function

Serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL/min

Liver function

Total bilirubin ≤1.5 × ULN, AST and ALT ≤2.5×ULN, Serum albumin ≥3 g/dL

Adequate bone marrow function as evidenced by: Absolute neutrophil count (ANC) ≥1.5×10^9/L, Platelet count ≥100×10^9/L, Hemoglobin (Hb) ≥90 g/L. Adequate hepatic function as evidenced by: Total bilirubin ≤1.5 × ULN, AST and ALT ≤2.5×ULN, Serum albumin ≥3 g/dL. Adequate renal function as evidenced by: Serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL/min.

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

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