TrialBridgeNCT07269249
Real-world Efficacy and Safety of Neoadjuvant Dostarlimab in Patients With dMMR/MSI-H Locally Advanced Rectal Cancer
Recruiting · Not specified · National Cancer Institute, Naples · registry updated 2025-12-08
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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 the retrospective part of the study:
- At least one dose of neoadjuvant dostarlimab from November 2023 (i.e. within the period of AIFA dostarlimab monitoring registry activation for the indication in rectal cancer, which is reimbursed according to the Italian law 648/1996, GU n.252 as of 27/10/2023)
Exclusion
- \- Distant metastasis
- Major cognitive dysfunction or psychiatric disorders
- Any previous systemic or local treatment for rectal cancer
- Dostarlimab received within an interventional clinical trial