NCT06443307

Real-world Study to Evaluate the Efficacy and Safety of Liposome Irinotecan

A Prospective, Multi-cohort, National Multicenter Real-world Study to Evaluate the Efficacy and Safety of Liposome Irinotecan

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 933 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study is a prospective, multicenter, real-world study. There are four cohorts. Cohorts 1-3 include second-line, posterior-line, and neoadjuvant colorectal cancer patients, respectively. Cohort 4 include patients with the exception of those with pancreatic and colorectal cancer. As this study is a real-world investigation, treatment procedures, visit schedules, and examinations will be based on the routine clinical practice of physicians. Through the above cohort, the efficacy and safety of irinotecan liposome are comprehensively observed.

Conditions

• Colorectal Cancer
• Solid Tumor

Interventions

Type	Name	Description
DRUG	Irinotecan Liposome	The experimental group will collect data from patients treated with Nal-IRI as the chemotherapy regimen. It is recommended to use according to the label, clinical practice shall prevail.

Timeline

• Start date: 2024-07-15
• Primary completion: 2026-07-01
• Completion: 2026-08-01
• First posted: 2024-06-05
• Last updated: 2024-06-05

Locations

1 site across 1 country: China