Tumor patients
Conditions
Interventions
Case series:Piperacil
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participated in this study and signed the informed consent; 2. Patients >= 18 years old; 3. The patient is diagnosed with malignant tumor and is receiving chemotherapy drugs. Treatment with a chemotherapy regimen containing 5-FU, or irinotecan, at the investigator's discretion; any such regimen may also include oxaliplatin, bevacizumab, or cetuximab; 4. The patient has diarrhea related to antitumor drugs, and the diarrhea symptom score is 1 or more according to NCI CTCAE v5.0;. 5. Patients can complete the questionnaire; 6. ECOG performance score <= 2.
Exclusion criteria
Exclusion criteria: 1. The patient suffered from diarrhea caused by non-anti-tumor drugs before enrollment, and had not fully recovered 4 weeks before the baseline; 2. The patient is using anti-diarrheal drugs, and the drug cannot be stopped 7 days before the baseline; 3. Previous or concurrent need for radiation therapy to the abdomen or pelvis; 4. Any type of condition that causes chronic diarrhea, including but not limited to inflammatory bowel disease (such as ulcerative colitis and Crohn's disease), chronic diarrhea of ??infectious origin, and irritable bowel syndrome; 5. The patient is suffering from other uncontrolled diseases, including but not limited to persistent or active infection, symptomatic congestive heart failure, unstable angina, recent myocardial infarction, uncontrolled hypertension or hypotension, Cardiac arrhythmias or psychopsychiatric disorders, and other social circumstances that may limit the patient's compliance with study requirements; 6. The patient has contraindications to the active ingredients of the test drug, including severe anemia, increased intracranial pressure, and known hypertension of grade III or higher; 7. The patient has used CDK4/6 inhibitors; 8. The patient has obvious laboratory abnormalities: (1) Poor hematopoietic function such as: neutrophil count 1.5 x ULN (if the patient is receiving anticoagulation therapy: PT INR > 3.5 x ULN ); (2) Poor liver and kidney function such as: albumin = 1.5 x ULN (>= 2.5 x ULN if the patient has Gilbert syndrome); AST, ALT, and ALP >= 2 x ULN (>= 5 x ULN if patient has liver cancer f); amylase and lipase >= 1.5 x ULN; creatinine > 2.0 x ULN; 9. The patient is a pregnant or lactating woman; 10. The patient is a woman with childbearing potential and is unwilling to take effective contraception two weeks before and during the test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grade score of Dirhoea; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life Assessment; | — |
Countries
China
Contacts
Public ContactTang Lina
Shanghai Sixth People's Hospital
Outcome results
None listed