None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : The schedule of this study is to gradually administer once daily for a total of 3 days per cycle for patients with effects of stable disease or higher in response
Sponsors
Chonnam National University Hospital Hwasun Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) histologically or cytologically diagnosed pancreatic adenocarcinoma 2) Age: 19 to 75 years old 3) Patients who had not previously been treated with chemotherapy and corresponded to stable lesion (SD), partial response (PR), and complete response (CR) in RECIST v1.1 evaluation after 3 cycles of mFOLFIRINOX administration in metastatic and/or locally advanced pancreatic adenocarcinoma determined to be impossible to resect surgery 4) If you are eligible for the following items ? Absolute neutrophil count (ANC) = 1,500/µL, platelets = 100,000/µL, hemoglobin (Hb) = 9 g/dL ? Serum aspartate transaminase (AST) and alanine transaminase (ALT) = 3 x upper limit of normal (ULN) (where there is liver metastasis = 5 x ULN), total bilirubin = 1.5 x ULN, serum albumin > 3 g/dL ? creatinine 30 mL/min) ? International normalized ratio(INR) < 1.5 5) When daily life performance capability is possible (ECOG physical activity is 0 or 1) 6) In women of childbearing age, the serum pregnancy test within one week of the start of mFOLFIRINOX administration should be negative. From the time of screening to the 6th month after final administration of mFOLFIRINOX and/or clinical research drugs, in men and women of childbearing age who are willing to continue using appropriate contraception methods 7) At least 2 weeks have passed since the operation, and there should be no aftereffects 8) If the life expectancy is more than 6 months 9) In the case of written consent from the study subject or agent who participated in this clinical study
Exclusion criteria
Exclusion criteria: 1) Previously, chemotherapy, targeted therapy, immunotherapy (monoclonal antibodies, cytokines, immune cell therapy, etc.), or other clinical trial drug treatment history 2) Central nervous system, mentally impaired or uncontrolled nervous system metastases 3) Allergic or hypersensitivity to combination drugs (oxaliplatin, irinotecan, leucovorin, 5-fluorouracil) or additives contained therein 4) If you have peripheral sensory neuropathy with functional impairment prior to the first dose cycle of mFOLFIRINOX 5) If autoimmune diseases are present 6) A history of other cancers (registration is possible for properly treated non-melanoma skin cancer, cured cervical cancer, or solid cancer treated without evidence of disease for more than five years) 7) If there is an infection that requires systemic treatment or is difficult to control 8) Known Gilbert syndrome, dehydro-pyridine dehydrogenase (DPD) deficiency, and UGT1A1*28 allele homozygous 9) If the combination of contraceptive drugs cannot be stopped 10) When the researcher judges that it is not appropriate for the subject to participate in clinical research or that the subject will not comply with research procedures, rules, or requirements 11) Those infected with hepatitis B or C. However, patients with past or cured HBV infection (prescribed as having anti-HBc antibodies and not having HbsAg) and appropriate prophylactic antiviral antibodies against positive HbsAg can be enrolled. In addition, patients who are positive for hepatitis C (HCV) antibodies can only be enrolled if they are negative for HCV RNA in a polymerase chain reaction. In addition, registration is possible only if it is negative for acquired immunodeficiency, syphilis, human T lymph-friendly virus, and giant cell virus. 12) When bone marrow function is suppressed 13) If you have diarrhea (only if you have severe diarrhea such as Grade 3 or Grade 4) 14) Chronic inflammatory bowel disease, intestinal paralysis, and intestinal obstruction 15) If you have interstitial pneumonia or pulmonary fibrosis 16) If there is a large amount of revenge and pleural effusion 17) If you have jaundice (serum total bilirubin greater than 2.1 mg/dL) 18) If atazanavir sulfate is being administered 19) For women who are pregnant or nursing 20) On dialysis 21) St. John's Wort is being administered
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| safety | — |
Countries
Korea, Republic of
Contacts
Public ContactIm Jeong Ah
Chonnam National University Hospital Hwasun Hospital
Outcome results
None listed