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NALIRIFOX + CRT in Locally Advanced Rectal Cancer
NCT06894797Phase 2
Key facts
- Status
- Recruiting
- Start
- Apr 2025
- Primary completion
- Oct 2026
- Countries
- 1
- Sponsor
- Peking University Cancer Hospital & Institute
- Modality
- Lipid-based Nanoparticles, Small Molecules
- Conditions
- rectal cancer
01
Overview
Phase 2, randomised, open-label trial of irinotecan liposome injection in rectal cancer (2 arms), sponsored by Peking University Cancer Hospital & Institute. Primary endpoint: Pathological Complete Response Rate at 3 months. Started Apr 2025; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Consolidation NALIRIFOX
CRT followed by NALIRIFOX
Induction NALIRIFOX
NALIRIFOX followed by CRT
03
Who it enrols
Patients with locally advanced rectal adenocarcinoma, MSS/pMMR, ECOG 0-1, and no prior systemic therapy.
04
Endpoints
Primary
Pathological Complete Response Rate
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