Clinical trial NCT07026123: A Real-world Study of Liposomal Irinotecan (Onivyde)-Based Therapy in Patients With Locally Advanced/Metastatic Pancreatic Cancer in China
Official title: A Real-world Study of Liposomal Irinotecan (Onivyde)-Based Therapy in Patients With Locally Advanced/Metastatic Pancreatic Cancer in China
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Advanced Pancreatic Cancer
Keywords: Pancreatic Cancer
chemotherapy
liposomal irinotecan
real world research
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Servier (Tianjin) Pharmaceutical Co. LTD.
First posted: 2025-06-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Experimental group: 40 patients Control group: Depends on the real world condition of China Pancreas Data Center (CPDC) project.

Brief summary: This study is designed to evaluate the real world efficacy and safety of the liposomal irinotecan (Onivyde®)-based treatment scheme in Chinese patients with locally advanced or metastatic pancreatic cancer, and to compare the efficacy with that of the whole pancreatic cancer population who did not receive relevant treatment.

Detailed description: Chinese patients with pancreatic cancer are mostly treated according to foreign clinical research, lacking the diagnosis and treatment data of efficacy and safety of Chinese population. In the NAPOLI-1 study, irinotecan liposomes (Onivyde®) The combination of 5-fluorouracil and folinic acid (Nal-IRI+5-FU/LV) has shown survival benefits in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) who have previously received gemcitabine-based treatment. The NAPOLI-3 study showed that NALIRIFOX (Nal-IRI+oxaliplatin+5-FU/LV) significantly improved overall survival (OS) and progression free survival (PFS) compared to albumin bound paclitaxel and gemcitabine in newly diagnosed mPDAC patients. However, the efficacy and safety data of Nal-IRI-based treatment regimens in China are limited. In August 2023, Onivyde® was commercially listed in China. The purpose of this study is to: ① evaluate the real world efficacy and safety of Onivyde®-based treatment schemes in Chinese patients with locally advanced or metastatic pancreatic cancer; ② analyze the efficacy of Onivyde® treatment and the efficacy of all pancreatic cancer patients who have not received relevant treatment using the project data of China Advanced pancreatic cancer Big Data Center (Renji Hospital Cancer Department is the national leading unit), in conjunction with the survival follow-up data of China Center for Disease Control and Prevention of Chronic Non communicable Diseases.

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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 24 months
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Up to 24 months
measure: Time To Progress (TTP)
timeFrame: Up to 24 months
measure: Overall Response Rate (ORR)
timeFrame: Up to 24 months
measure: Disease Control Rate (DCR)
timeFrame: Up to 24 months
measure: Safety and tolerability by incidence, severity and outcome of adverse events
timeFrame: Until 30 day safety follow-up visit
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Liwei Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: