Neoadjuvant dostarlimab for locally advanced dMMR/MSI‑H rectal cancer in routine practice

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicentre, observational retrospective‑prospective study enrolling patients entered in the Italian AIFA monitoring registry who received neoadjuvant dostarlimab beginning in November 2023. The primary outcome is objective response rate by RECIST 1.1, with central radiology review planned for objective responses. Secondary outcomes include clinical complete and near‑complete response rates at 6 and 12 months, time to and duration of responses, surgical and pathological response rates, safety using CTCAE v5.0, and longer‑term outcomes such as event‑free survival, organ preservation at 3 years, time to distant recurrence, and overall survival. Data will be collected across participating Naples centers to describe real‑world effectiveness and toxicity outside a controlled trial setting.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Maria Carmela Piccirillo, MD — National Cancer Institute, IRCCS Fondazione G. Pascale
• Study coordinator: Maria Carmela Piccirillo, MD
• Email: m.piccirillo@istitutotumori.na.it
• Phone: +39 08117770280

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.