NCT07269249 Real-world Efficacy and Safety of Neoadjuvant Dostarlimab in Patients With dMMR/MSI-H Locally Advanced Rectal Cancer
| NCT ID | NCT07269249 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cancer Institute, Naples |
| Condition | Locally Advanced Rectal Cancer (LARC) |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2025-09-01 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 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
Contact & Investigator
Maria Carmela Piccirillo, MD
PRINCIPAL INVESTIGATOR
National Cancer Institute, IRCCS Fondazione G. Pascale
Frequently Asked Questions
Who can join the NCT07269249 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Locally Advanced Rectal Cancer (LARC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07269249 currently recruiting?
Yes, NCT07269249 is actively recruiting participants. Contact the research team at m.piccirillo@istitutotumori.na.it for enrollment information.
Where is the NCT07269249 trial being conducted?
This trial is being conducted at Naples, Italy, Naples, Italy.
Who is sponsoring the NCT07269249 clinical trial?
NCT07269249 is sponsored by National Cancer Institute, Naples. The principal investigator is Maria Carmela Piccirillo, MD at National Cancer Institute, IRCCS Fondazione G. Pascale. The trial plans to enroll 50 participants.
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