RecruitingNCT07269249

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

Sponsor

National Cancer Institute, Naples

Enrollment

50 participants

Start Date

Sep 1, 2025

Study Type

OBSERVATIONAL

Conditions

Locally Advanced Rectal Cancer (LARC)

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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)
Eligible deceased or unreachable patients will also be included to avoid selection biases, in respect of the article 110 bis, paragraph 4 of the Italian Privacy Code (a Data Protection Impact Assessment will be produced and published on the Sponsor website before study initiation, and patients explicitly unwilling before death will be not included).
For the prospective part of the study:
\- Inclusion in the AIFA dostarlimab monitoring registry for the indication in rectal cancer, to receive dostarlimab according to the Italian law 648/1996, GU n.252 as of 27/10/2023