Clinical Trial

Irinotecan Liposomes in Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer

Study acronym: CinClare-2
Not Yet Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This study enrolled patients with locally advanced rectal cancer. The experimental group received irinotecan liposomes combined with standard total neoadjuvant therapy (TNT), while the control group received standard TNT. The study endpoints were the complete response rate (cCR + pCR), 3-year event-free survival (EFS) rate, and overall survival (OS). The aim was to compare the efficacy and safety of irinotecan liposomes combined with or without standard TNT.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-17.
Trial Details
NCT Number NCT07074353
Lead Sponsor Zhejiang Cancer Hospital
Conditions Locally Advanced Rectal Cancer
Enrollment 360 participants
Start Date 2025-07-20
Primary Completion 2028-04-01 (estimated)
Study Completion 2030-07-01 (estimated)
Updated on ClinicalTrials.gov 2025-07-25