Clinical trial · Observational
Real-world Efficacy and Safety of Neoadjuvant Dostarlimab in Patients With dMMR/MSI-H Locally Advanced Rectal Cancer
NCT07269249CI-TRIAL-00098557RW-NEDOSrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Rectal Cancer (LARC) | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dostarlimab | Drug | Dostarlimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Stage II-III rectal cancer (LARC)
- description
- patients with dMMR/MSI LARC treated with neoadjuvant dostarlimab
- interventionNames
- Drug: Dostarlimab
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- after 3 , 6 and 9 cycles of dostarlimab. Each cycle is 21 days. Up to 6 months
- description
- Defined as the percentage of trial participants having a CR or PR, as per RECIST v1.1.
Secondary outcomes (10)
- measure
- duration of clinical complete response
- timeFrame
- up to to 12 months
- description
- defined as the time from the first documented date of clinical complete response to the date of documented local tumor regrowth, disease recurrence, or last available follow-up, whichever occurs first.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.