Actively Recruiting
Real-world Efficacy and Safety of Neoadjuvant Dostarlimab in Patients With dMMR/MSI-H Locally Advanced Rectal Cancer
Led by National Cancer Institute, Naples · Updated on 2025-12-08
50
Participants Needed
2
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an observational, retrospective-prospective, multicentre trial enrolling all patients included in the AIFA monitoring registry of Dostarlimab for the indication in rectal cancer. The aims of the study are to describe the clinical outcomes and safety of patients with dMMR/MSI-H locally advanced rectal cancer (LARC) receiving neoadjuvant dostarlimab in the real-world setting.
CONDITIONS
Official Title
Real-world Efficacy and Safety of Neoadjuvant Dostarlimab in Patients With dMMR/MSI-H Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Age > 18 years
- Histologically confirmed stage II-III rectal cancer
- dMMR/MSI status assessed locally by Immunohistochemistry, next-generation sequencing or PCR
- For retrospective patients: at least one dose of neoadjuvant dostarlimab from November 2023
- Eligible deceased or unreachable patients may be included to avoid bias
- For prospective patients: inclusion in the AIFA dostarlimab monitoring registry for rectal cancer indication
You will not qualify if you...
- Presence of distant metastasis
- Major cognitive dysfunction or psychiatric disorders
- Any previous systemic or local treatment for rectal cancer
- Receiving dostarlimab as part of an interventional clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
ASL Napoli 1, Presidio Ospedaliero Ospedale del mare, Oncologia medica
Naples, Italy, 80131
Not Yet Recruiting
2
IRCCS Fondazione G. Pascale, Unità Operativa Complessa Oncologia Addominale
Naples, Italy
Actively Recruiting
Research Team
M
Maria Carmela Piccirillo, MD
CONTACT
P
Piera Gargiulo, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here