Real-world Efficacy and Safety of Neoadjuvant Dostarlimab in Patients With dMMR/MSI-H Locally Advanced Rectal Cancer

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.

NCT Number	NCT07269249
Lead Sponsor	National Cancer Institute, Naples
Conditions	Locally Advanced Rectal Cancer (LARC)
Enrollment	50 participants
Start Date	2025-09-01
Primary Completion	2027-01 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2025-12-08