A randomized Phase II study of second line treatment with liposomal irinotecan and S1 versus liposomal irinotecan and 5-fluorouracil in patients with metastatic pancreatic cancer who failed on first line gemcitabine-based chemotherapy

Academic Medical Center0 个研究点目标入组 120 人开始时间: 2019年11月25日最近更新: 2020年11月3日

适应症

试验速览

暂无简介。

•Able to understand and provide written informed consent
•= 18 years of age
•Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas
•Documented metastatic disease
•Previously treated with gemcitabine or gemcitabine containing therapy, or progression within 6 months of adjuvant gemcitabine treatment
•Adequate hepatic, renal and hematological function
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 80
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•Any clinically significant gastrointestinal disorder, including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea > grade 2
•Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) in last 6 months
•NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure. Or known abnormal ECG with clinically significant abnormal findings
•Active infection or an unexplained fever >38.5°C (excluding tumor fever), which in the physician’s opinion might compromise the patient’s health
•Current use or any use in last two weeks of strong CYP3A-enzyme inducers/inhibitors and/or strong UGT1A inhibitors
•Known hypersensitivity to any of the components of liposomal irinotecan (nal-IRI) other liposomal irinotecan formulations, irinotecan, fluoropyrimidines, or leucovorin.
•Hypersensitivity to any of the active substances (tegafur, gimeracil, and oteracil)
•History of severe and unexpected reactions to fluoropyrimidine therapy
•Known dihydropyrimidine dehydrogenase (DPD) deficiency
•Breast feeding, known pregnancy, positive serum pregnancy test or unwillingness to use a reliable method of birth control, during therapy and for 3 months following the last dose of liposomal irinotecan (nal-IRI).
•Treatment within 4 weeks with DPD inhibitors, including sorivudine or its chemically related analogues such as brivudine

发起方

Academic Medical Center