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

Prior treatment

• Any clinical indicators indicating contraindications to radiotherapy/chemotherapy and surgery.
• Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1.

Other illness

• Any other malignancy within 5 years, with the exception of cured in-situ carcinoma or basal cell carcinoma etc.
• Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment.
• Active HIV infection.
• Combined with uncontrollable systemic diseases.
• History of allergy or hypersensitivity to drug or any of their excipients.
• Patients with poor cognitive abilities who are unable to answer questions, fill out questionnaires, or have mental disorders.

Age

• Pregnant or breastfeeding women, or subjects of childbearing age who refuse contraception.

Other

• Patients who do not meet the inclusion criteria; patients who meet the inclusion criteria but are not suitable to participate in this trial judged by the investigator.

• Age: 18\~75 years old.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0\~1.
• Histopathologically confirmed rectal adenocarcinoma.
• The lower edge of the primary tumor is located below the peritoneal reflection or located ≤ 10 cm above the anal verge.
• Clinical stage: T3-4NanyM0 or T1-2N+M0.
• 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 × upper limit of normal (ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN, Serum albumin ≥3 g/dL.
• Adequate renal function as evidenced by: Serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance ≥60 mL/min.
• Be willing to undergo UGT1A1 gene testing and UGT1A1 genotype of \*1\*1 or \*1\*28.
• Accept the neoadjuvant chemoradiotherapy protocol of this study and sign the informed consent.