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 (thelast dose of irinotecan is administered within 1 month);

5. Patients who plan to receive 3 cycles of irinotecan chemotherapy (the dose ofirinotecan ≥ 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/orcreatinine clearance ≥ 60ml/min;

• Normal hepatic functions: total serum bilirubin level ≤ 1.5 times of the upperlimit of normal value (ULN), serum aspartate aminotransferase (AST) & alanineaminotransferase (ALT) ≤ 2.5× ULN; AST & ALT ≤ 5 × ULN if abnormal hepaticfunctions 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.

Exclusion Criteria:

1. Patients with diagnosed depression, obsession or/and schizophrenia;

2. Patients with diagnosed inflammatory bowel diseases (including Crohn's disease,ulcerative colitis)

3. Patient with active tuberculosis and other uncontrolled infections;

4. Patient who has previously received radiotherapy on the abdominal cavity or pelviccavity;

5. Pregnant or lactating women;

6. Patient who previously had or is now having thromboembolic events.