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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)
Sponsor: Servier (Tianjin) Pharmaceutical Co. LTD.
Summary
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
120
Start Date
2024-11
Completion Date
2027-07
Last Updated
2024-11-14
Healthy Volunteers
No