gastrointestinal cancer
Conditions
Interventions
1:Palonosetron 0.25mg iv d1 + Olanzapine 5mg po d1-3
2:Palonosetron 0.25mg iv d1 + Dexamethasone 5mg iv d1
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed gastrointestinal tumors: gastric cancer, colorectal cancer, biliary tract tumor, pancreatic cancer; 2. Subjects older than 18 years; 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 4. The initial chemotherapy regimen is oxaliplatin-containing chemotherapy +/- immunotherapy or intravenous targeted therapy: oxaliplatin-containing regimens (SOX, XELOX/Capeox, FOLFOX, GemOX) +/- immunotherapy or intravenous targeted therapy; 5. Hematology, liver and kidney function and important organ function indicators meet the requirements of chemotherapy; 6. Blood routine examination: absolute neutrophil count (ANC) >= 1.5×109/L, platelet (PLT) >= 80×109/L, hemoglobin (HGB) >= 80g/L; 7. Biochemical examination: serum creatinine (Cr) <= 1.5 x upper limit of normal value; total bilirubin (TBI) <= 2.5 x upper limit of normal value, alanine transaminase (ALT) aspartate aminotransferase (AST) and alkaline phosphatase (ALP) <= 2.5 x upper limit of normal value (ALT and AST <= x upper limit of normal value in patients with liver metastasis, ALP <= 10 x upper limit of normal value in patients with bone metastasis); 8. For fertile women, a negative pregnancy test, and adequate birth-control measure throughout the whole study period; 9. All patients were informed of the investigational nature of this study and provided written informed consent before inclusion.
Exclusion criteria
Exclusion criteria: 1. Allergic to olanzapine, dexamethasone, and palonosetron; 2. Patients undergoing a total gastrectomy; 3. Abdominal radiotherapy before or during enrollment; 4. People with central neuro system disorders (e.g., brain metastases or epilepsy); 5. People with psychiatric disorders; 6. Diabetes; 7.Those who took other antipsychotic medications, such as risperidone, quetiapine, clozapine, phenothiazine, or butylphthalide within 30 days before or during enrollment; 8. Known arrhythmias, uncontrollable congestive heart failure or acute myocardial infarction within the past 6 months; 9. Nausea and vomiting due to any cause occurred within three days prior to enrolment; 10. History of active peptic ulcers and gastrointestinal bleeding within one year; 11. Long-term hormone users (including immune system disorders such as systemic lupus erythematosus, adrenocortical insufficiency, etc.); 12. Pregnant or lactating women; 13. Subjects who could not read or complete the questionnaire independently; 14. Subjects who cannot take medication orally; 15. The researchers did not consider it suitable for enrollees.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the rate of complete response (0-120h); | — |
Secondary
| Measure | Time frame |
|---|---|
| the rate of complete response (0-24h);the rate of complete response (24-120h);the rate of complete control (0-24h);the rate of complete control (24-120h); | — |
Countries
China
Contacts
Public ContactCao Dan
West China Hospital, Sichuan University
Outcome results
None listed