Patients with advanced gastrointestinal cancer
Conditions
Interventions
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years, ECOG performance status = 3 months; 2.Received standard-dose irinotecan liposome (e.g., 70 mg/m^2, q2w); 3.No prior treatment with other potent UGT1A1 inducers or inhibitors (e.g., phenytoin sodium, valproic acid).
Exclusion criteria
Exclusion criteria: 1.Severe hepatic dysfunction (Child-Pugh Class C or ALT/AST >5×ULN); 2.Active infection or insufficient bone marrow reserve (baseline ANC <1.5×10^9/L, PLT <75×10^9/L); 3.Prior history of irinotecan treatment (to avoid adaptive interference with metabolic enzymes);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grade >=3 adverse reactions related to liposomal irinotecan treatment;The plasma drug concentrations of liposomal irinotecan and its metabolites; | — |
Secondary
| Measure | Time frame |
|---|---|
| Grade < 3 adverse reactions related to liposomal irinotecan treatment; | — |
Countries
China
Contacts
Public ContactShuowen Wang
Shanghai General Hospital
Outcome results
None listed