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Nr-CWS in Advanced Colorectal Cancer with Hazardous Stable Disease
NCT06356714Phase 2
Key facts
- Status
- Recruiting
- Start
- Mar 2025
- Primary completion
- Sep 2026
- Countries
- 1
- Modality
- Prophylactic Vaccines, Therapeutic Vaccines
- Conditions
- colorectal cancer (CRC)
01
Overview
Phase 2, open-label, single-arm trial of nocardia rubra cell wall skeleton in colorectal cancer (CRC). Primary endpoint: Progression-free survival at 1 year. Started Mar 2025; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Nocardia Rubra Cell Wall Skeleton + Prior Regimen
Nocardia Rubra Cell Wall Skeleton added to prior second- or third-line regimens
03
Who it enrols
Patients with advanced or metastatic colorectal adenocarcinoma who have received prior second- or third-line therapy and present with a potentially hazardous Stable Disease (SD) status defined by specific RECIST and CEA/CA19-9 criteria.
04
Endpoints
Primary
Progression-free survival
Secondary
Overall survival
Objective remission rate
Disease Control Rate
Incidence and extent of major security incidents
Quality of Life Score
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