None listed
Conditions
Interventions
Drug, Biological/Vaccine, Non-Stem Cell : It was determined by reflecting the schedule of gemcitabine and capecitabine used as standard treatment for pancreatic cancer. Gemcitabine is administered o
Sponsors
Dong-A University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with histologically or cytologically confirmed pancreatic adenocarcinoma after undergoing radical resection 2) Pathologically confirmed stage 1 to 3 patients based on AJCC 8th edition 3) Age 19 or older 4) Ability to perform daily activities -Patients with ECOG (Eastern Cooperative Oncology Group) scale = 2 5) Patients with adequate bone marrow function ? Absolute Neutrophil Count = 1,500/? ? Hemoglobin = 8.0g/dL ? Platelet Count = 100,000/?) 6) Patients with adequate liver and renal function ? Total bilirubin = 1.5 X ULN ? AST/ALT <2.5?ULN, ALP <5?ULN (However, AST/ALT <5?ULN with liver metastases) ? Normal renal function (serum creatinine = 2 times the normal value) 7) A person who has written consent from the patient or legal representative 8) Female is a patient who was negative in a urine or blood pregnancy test 7 days before the first administration of clinical research drug and agreed to use appropriate contraception during the study period
Exclusion criteria
Exclusion criteria: 1) Patients who have not recovered from serious complications of pancreatectomy 2) Patients with distant metastasis or who underwent symptomatic resection when curative resection was not possible 3) Evidence of metastatic disease (including presence of tumor cells in ascites) 4) Past chemotherapy or radiotherapy for currently treated pancreatic cancer 5) Patients with a history of cancer other than pancreatic cancer within 3 years 6) Those who participated in other clinical studies within 4 weeks before the start of study drug administration in this study 7) Pregnant and lactating women 8) Active viral infection (However, if you are a carrier of hepatitis B, you can register if the HBV DNA titer is 20,000 IU/mL or less, and antiviral agents for hepatitis B can be used prophylactically according to the doctor's judgment) 9) Active HIV infection 10) Actively infected persons with serious bacterial, viral, or fungal infections or requiring systemic medical treatment 11) Those who are judged unsuitable for clinical research due to accompanying serious medical or psychiatric diseases 12) Those with severe heart disease (myocardial infarction/angina pectoris/severe arrhythmia/congestive heart failure) 13) Patients currently being treated for autoimmune diseases (lupus erythematosus/rheumatoid arthritis/myasthenia gravis) 14) Patients who have taken immunosuppressive drugs including steroids within 4 weeks (However, topical steroids, inhaled steroids, and low-dose oral steroids (prednisone 10mg/day or less) are permitted.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival | — |
Countries
Korea, Republic of
Contacts
Public ContactSEOK JAE HUH
Dong-A University Hospital
Outcome results
None listed