None listed
Conditions
Interventions
Drug : This study is a single-arm trial and mFOLFIRINOX therapy, the backbone therapy of this trial, chlorphenesin carbamate 250 mg, and hydroxychloroquine 200 mg will be administered orally twice dai
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults of age = 19 and < 80 years 2) A patient who meets any of the following criteria at the time of screening or before, and who is scheduled to receive chemotherapy with modified FOLFIRINOX for the first time after screening • Locally advanced inoperable pancreatic cancer • Metastatic pancreatic cancer 3) One or more measurable lesions by RECIST v 1.1 4) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) o pr 1 5) Estimated life expectancy of at least 12 weeks or more at the discretion of the investigator
Exclusion criteria
Exclusion criteria: 1) History of major surgery within 4 weeks at the time of screening 2) Symptomatic, uncontrolled brain metastasis or meningeal carcinomatosis 3) History of malignancy within 5 years at the time of screening 4) History of human immunodeficiency virus (HIV) or active hepatitis 5) Active infection requiring systemic antibiotic therapy 6) Patients who have maculopathy or are receiving treatment for corneal or retinal disease, or under follow-up 7) History of acute or subacute intestinal obstruction or paralytic ileus, or a history of chronic diarrhea considered clinically significant at the discretion of the investigator 8) Serious neurological, psychiatric condition including drug abuse or alcoholism, which would prevent the subject from participating in the study 9) Patients with any condition who are considered unsuitable for participation in the study in the judgment of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AE, Lab Test, Vital sign, 12-lead ECG, Physical examination, ECOG PS | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS Rate;DMFS Rate | — |
Countries
Korea, Republic of
Contacts
Public ContactChanghoon Yoo
Asan Medical Center
Outcome results
None listed