XCHT for Irinotecan-Induced Gut Toxicities (Randomized Controlled Trial)

Inclusion Criteria

• •1. Malignant tumor confirmed by histology or cytology;
• •2. Age ≥ 18 years old, ≤ 75 years old;
• •3. ECOG score of the patient ≤ 2 points;
• •4. Patients who have diarrhea worse than grade 2 due to irinotecan chemotherapy (the last dose of irinotecan is administered within 1 month);
• •5. Patients who plan to receive 3 cycles of irinotecan chemotherapy (the dose of irinotecan ≥ 125mg/m2);
• •6. Normal organ functions which can meet the requirements for systemic chemotherapy:
• •* Normal bone marrow function: absolute neutrophil count (ANC) ≥ 1.5×109/L, PLT ≥ 100×109/L, hemoglobin ≥ 90g/L;
• •* Normal renal functions: serum creatinine ≤ 1.5mg/dl (133μmol/L) and/or creatinine clearance ≥ 60ml/min;
• •* Normal hepatic functions: total serum bilirubin level ≤ 1.5 times of the upper limit of normal value (ULN), serum aspartate aminotransferase (AST) \& alanine aminotransferase (ALT) ≤ 2.5× ULN; AST \& ALT ≤ 5 × ULN if abnormal hepatic functions are caused by a potentially malignant tumor.
• •7. Patients who can understand and complete the questionnaires in the case report form;
• •8. Patients who can understand and sign the informed consent form, is well compliant, and can be followed up.