drugset / Trial / NCT07074353

Irinotecan Liposomes in Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer

NCT07074353 ↗

Phase 3 Not yet recruiting 360 enrolled Zhejiang Cancer Hospital
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-07-20
Primary completion
2028-04-01
Completion
2030-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule — —
Background Leucovorin Small molecule — —
Background Oxaliplatin Small molecule — —
Background fluorouracil Small molecule — —

Indications

No indication recorded.