Clinical Trial

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)

Study acronym: SEOPAC
Not Yet Recruiting
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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
Trial Details
NCT Number NCT06688240
Lead Sponsor Servier (Tianjin) Pharmaceutical Co. LTD.
Collaborators: Les Laboratoires Servier
Conditions Metastatic Pancreatic Cancer
Enrollment 120 participants
Start Date 2024-11
Primary Completion 2027-07 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2024-11-14