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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNational Cancer Institute, Naples

About this trial

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 criteria

Qualifiers

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

Disqualifiers

- Distant metastasis

Major cognitive dysfunction or psychiatric disorders

Any previous systemic or local treatment for rectal cancer

Dostarlimab received within an interventional clinical trial

Trial design

Treatments tested in this trial

  • Dostarlimab

Treatment groups

50 Participants
are divided into 1 treatment group