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Clinical Trials in Italy / NCT07269249
Recruiting Observational

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

NCT07269249 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-09-01
Last updated
2025-12-08

Condition(s) studied

Locally Advanced Rectal Cancer (LARC)

Investigational drug(s) / intervention(s)

Dostarlimab →

Dostarlimab: Dostarlimab 500 mg iv every 3 weeks for 9 cycles

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * \- Distant metastasis * Major cognitive dysfunction or psychiatric disorders * Any previous systemic or local treatment for rectal cancer * Dostarlimab received within an interventional clinical trial

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
ASL Napoli 1, Presidio Ospedaliero Ospedale del mare, Oncologia medica Naples Italy Not Yet Recruiting
IRCCS Fondazione G. Pascale, Unità Operativa Complessa Oncologia Addominale Naples Italy Recruiting

More National Cancer Institute, Naples trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07269249 on ClinicalTrials.gov ↗ ← All trials in Italy