None listed
Conditions
Interventions
Drug : Eflapegrastim (Rolontis prefilled syringe injection) 13.2 mg/0.6 ml
Subcutaneous injection 24 hours after completion of anticancer chemotherapy, administered for the first 6 cycles, and then ad
Sponsors
Ajou University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed locally advanced or metastatic pancreatic adenocarcinoma that is inoperable 2) ECOG performance status 0 - 2 3) Patients aged 19 to 64 years 4) Patients scheduled to receive chemotherapy (FOLFIRINOX or modified FOLFIRINOX) 5) Patients who have not previously received chemotherapy 6) Patients who voluntarily gave written consent to the research subject consent form before participating in this clinical trial 7) Patients who used appropriate contraception during the clinical trial and up to 120 days after the last dose of the study drug Contraceptive methods using oral contraceptives, intrauterine devices, spermicidal jelly, or surgically sterilized patients who agreed to the procedure Fertile women are women who are not surgically sterilized or who have not had menstruation for more than 1 year
Exclusion criteria
Exclusion criteria: 1) Neuroendocrine tumors other than adenocarcinoma, etc. 2) History of other malignant tumors, except for cases with no recurrence for more than 3 years after curative treatment for non-melanoma skin cancer, intraepithelial carcinoma, or other malignant tumors such as breast cancer or prostate cancer that received appropriate treatment 3) Patients with severe uncontrolled systemic disease, abnormal laboratory test results below, psychiatric illness, or other accompanying diseases that may impair the ability to participate in the clinical trial or make the interpretation of the clinical trial results difficult - Neutrophils < 1.5 x 109/L, platelets < 100 x 109/L, or hemoglobin < 9 g/dL - Serum bilirubin 1.5 x ULN, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 5.0 x ULN) - Serum creatinine 1.5 x ULN, Creatinine Clearance < 3 0 mL/min) 4) Severe systemic infections (bacteria, viruses, fungi, etc.) that are not controlled or require intravenous antibiotic therapy 5) Human immunodeficiency virus (HIV) (patients with a known history of HIV 1/2 antibodies 6) Patients with known active hepatitis A or B, except hepatitis B with HBV DNA = 1000 copies/ml while receiving antiviral therapy for hepatitis B 7) Pregnant or lactating women. Positive pregnancy test result among women of childbearing age 8) Patients with the following contraindications - Those with a history of hypersensitivity to E. coli-derived drugs and 5 FU, leucovorin, irinotecan, and oxaliplatin - Those known to have DPD (dihydro pyridine dehydrogenase) deficiency - Those taking a combination drug of tegafur, gimeracil, and oteracil potassium or those who have stopped taking it within 7 days - Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Grade 3/4 Neutropenia;Adverse event (AE) and serious adverse event (SAE) incidence | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Grade 3/4 Neutropenia;Incidence of febrile neutropenia | — |
Countries
Korea, Republic of
Contacts
Public ContactSumi Kim
Ajou University Hospital
Outcome results
None listed