A Real-world Study of Liposomal Irinotecan (Onivyde)-Based Therapy in Patients With Locally Advanced/Metastatic Pancreatic Cancer in China

Launched by RENJI HOSPITAL · Jun 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called liposomal irinotecan (brand name Onivyde®) combined with other medicines, to see how well it works and how safe it is for people in China who have advanced pancreatic cancer that cannot be removed by surgery or has spread to other parts of the body. The researchers want to compare patients who receive this treatment to those who do not, so they can better understand its benefits in real-life settings.

Adults aged 18 and older with advanced pancreatic cancer may be eligible to join. To take part in the treatment group, patients must have already tried and seen their cancer grow despite previous chemotherapy with a drug called gemcitabine. They should have received at least one cycle of the Onivyde-based treatment. Those in the comparison group have similar cancer but have not been treated with Onivyde. Pregnant or breastfeeding women and patients without available medical data cannot join. Participants who take part will be monitored to see how the treatment affects their cancer and overall health. This study has not started recruiting yet, but it aims to provide helpful information for patients and doctors about using this treatment in everyday medical care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria of the experimental group:
• • Age ≥ 18 years old.
• • Patients with locally advanced or metastatic PDAC diagnosed by pathology.
• • Patients who received at least one cycle of Nal-IRI (Onivyde®）+ 5-FU/LV treatment.
• • Patients who have progressed in treatment with gemcitabine or gemcitabine containing regimens in the past.
• • The patient voluntarily participates in the study and signs an informed consent form.
• Inclusion Criteria of the control group:
• • Age ≥ 18 years old.
• • Patients with locally advanced or metastatic PDAC diagnosed by pathology.
• • Not received Nal IRI (Onivyde®)+ 5-FU/LV treatment in the past.
• Exclusion Criteria:
• • Confirm pregnant or lactating women.
• • The patient's clinical data is not available.
• • The researchers determined that they were not suitable for inclusion in the study due to other circumstances.