NCT07074353

Irinotecan Liposomes in Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer

A Randomized, Multicenter Clinical Study of Irinotecan Liposomes in Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Locally Advanced Rectal Cancer

Interventions

Type	Name	Description
DRUG	NALIRI	Irinotecan liposomes
RADIATION	LCRT	Long-course concurrent chemoradiotherapy
DRUG	FOLFOX	Fluorouracil/Leucovorin, Oxaliplatin (5-FU/LV, OX)

Timeline

• Start date: 2025-07-20
• Primary completion: 2028-04-01
• Completion: 2030-07-01
• First posted: 2025-07-20
• Last updated: 2025-07-25

Locations

1 site across 1 country: China