Dostarlimab for Locally Advanced Rectal Cancer

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

Recruiting Observational Study
Locally Advanced Rectal Cancer (LARC)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
50 (estimated)
Sponsor
National Cancer Institute, Naples · Other
Who this trial is looking for

This trial is looking for adults with a specific type of rectal cancer who would like to receive a treatment called dostarlimab. Participants will be part of a study to see how well this treatment works and its safety in real-life situations.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am over 18 years old.
  • I have locally advanced rectal cancer diagnosed by a doctor.
  • I have a certain genetic status called dMMR/MSI-H.
  • I have signed an informed consent form.
  • I have received at least one dose of dostarlimab since November 2023.
  • I am listed in the AIFA dostarlimab monitoring registry for rectal cancer.

You may not be able to join if

  • I have distant metastasis.
  • I have major cognitive dysfunction or psychiatric disorders.
  • I have had any previous treatment for rectal cancer.
  • I have received dostarlimab as part of another clinical trial.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
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.

Trial Locations
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Eligibility Criteria
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 dost…
Contacts

Maria Carmela Piccirillo, MD

+39 08117770280

m.piccirillo@istitutotumori.na.it

CONTACT

Piera Gargiulo, MD

+39 081 1777 0279

piera.gargiulo@istitutotumori.na.it

CONTACT