Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07026123

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

Sponsor: RenJi Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

40

Start Date

2025-07-01

Completion Date

2027-07-31

Last Updated

2025-06-18

Healthy Volunteers

No

Interventions

DRUG

Nal-IRI (Onivyde®)-based treatment

Nal-IRI (Onivyde®) combined with 5-FU/LV is used for metastatic pancreatic ductal adenocarcinoma patients who have progressed after treatment with gemcitabine. The recommended dose of Nal-IRI (Onivyde®) is 70 mg/m\^2, administered intravenously for 90 minutes, once every 2 weeks. In patients known to be homozygous for the UGT1A1 \* 28 allele, the recommended starting dose of Nal-IRI (Onivyde®) is 50 mg/m\^2, administered intravenously within 90 minutes. Based on tolerance, increase the dose of Nal-IRI (Onivyde®) to 70 mg/m\^2 in subsequent cycles.

DRUG

Other second-line treatment

Other second-line treatment

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China