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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 (Jun 2026). This Phase 2 trial studies multiple treatments including liposomal irinotecan and Capecitabine for rectal cancer.

Phase 2RecruitingHebei Medical University Fourth HospitalNCT06210971Data as of Jun 2026Location: China

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

Treatments studied

Chemotherapy

liposomal irinotecanCapecitabine

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)

Demographics

Ages ≤ 75

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.

Frequently asked questions

Is NCT06210971 currently recruiting?

Yes, this trial is currently recruiting patients.

Does this trial require UGT1A1?

Yes, UGT1A1 *1*1 is a required biomarker for enrollment.

Does this trial require UGT1A1?

Yes, UGT1A1 *1*28 is a required biomarker for enrollment.

What disease stage is eligible?

Stage T3-4NANYM0 or T1-2N+M0 is required.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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