An Open Label, Single-Arm, Phase I Exploratory Trial to Assess the Safety and Preliminary Efficacy of mFOLFIRINOX with Hydroxychloroquine and Chlorphenesin carbamate in Patient with in Inoperable Locally Advanced or Metastatic Pancreatic Cancer

Asan Medical Center0 个研究点目标入组 40 人开始时间: 待定最近更新: 2023年5月2日

试验速览

暂无简介。

•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

•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

发起方