A Multi-center, Single-arm, Prospective Non-interventional Study to Investigate the Safety Profiles and Effectiveness of Liposomal Irinotecan (ONIVYDE®) in Combination with 5-fluorouracil (5-FU) and Leucovorin (LV) in Chinese Patients with Metastatic Pancreatic Cancer As Approval Condition (SEOPAC)
The aim of this phase 4 study is to evaluate the safety profile of ONIVYDE in China mainland. Primary objective To characterize the safety of ONIVYDE when used under standard clinical practice in China mainland on the following aspects: 1. Quantify the rate of grade ≥3 neutropenia (primary objective) 2. Serious adverse events and serious adverse drug reactions 3. Adverse events and adverse drug reactions Secondary objective To describe effectiveness in patients receiving ONIVYDE in combination with 5-FU and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in China mainland. (1) Overall survival (2) Overall response (3) Progression free survival (4) Quality of life assessment
The adult patient (≥18 years of age) has given written informed consent to parti... [+4]
Patients who have experienced a severe hypersensitivity reaction to ONIVYDE or I... [+4]