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Идёт набор NCT07269249

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

— Наблюдательное Locally Advanced Rectal Cancer (LARC)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Dostarlimab.
Кому может быть актуально
Состояния в реестре: Locally Advanced Rectal Cancer (LARC). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

The primary objective is to describe the activity of neoadjuvant dostarlimab in terms of objective response rate (RECIST 1.1).

Secondary objectives are:

1. To describe the activity of neoadjuvant dostarlimab in terms of:

* complete clinical response rate at 6 and 12 months * time to clinical complete response * duration of clinical complete response * near-complete clinical response rate at 6 and 12 months * duration of near-complete clinical response * duration of objective response * rate of surgery (total mesorectal excision or local excision) * pathological complete response rate * objective response rate (RECIST 1.1) assessed by central radiological review. 2. To describe the safety of neoadjuvant dostarlimab in terms of: Adverse events/SAE incidence and outcome, time and duration of toxicity according to CTCAE v5.0. 3. To descrive the efficacy of neoadjuvant dostarlimab in terms of: event free-survival (EFS), organ preservation at 3 years, time to ditance recurrence and overall survival (OS)

Вмешательства

  • Препарат Dostarlimab
    Dostarlimab 500 mg iv every 3 weeks for 9 cycles

Первичные конечные точки

  • Objective response rate (ORR) [Срок оценки: after 3 , 6 and 9 cycles of dostarlimab. Each cycle is 21 days. Up to 6 months]
Вторичные конечные точки (10)
  • duration of clinical complete response [Срок оценки: up to to 12 months]
  • near-complete clinical response rate [Срок оценки: at 6 and 12 months up to 12 months]
  • duration of near-complete clinical response [Срок оценки: up to 12 months]
  • rate of surgery (total mesorectal excision or local excision) [Срок оценки: at 6 months (at the end of neoadjuvant dostarlimab)]
  • pathological complete response rate [Срок оценки: after surgery (at 6 months)]
  • objective response rate assessed by central radiological review [Срок оценки: fter 3 , 6 and 9 cycles of dostarlimab. Each cycle is 21 days. Up to 6 months]
  • safety of neoadjuvant dostarlimab [Срок оценки: at the end of each cycle of dostarlimab (every 21 days ) up to 6 months]
  • Event-free survival [Срок оценки: up to 12 months]
  • Time to distant recurrence [Срок оценки: up to 12 months]
  • Overall survival [Срок оценки: up to 12 months]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • \- Distant metastasis
  • Major cognitive dysfunction or psychiatric disorders
  • Any previous systemic or local treatment for rectal cancer
  • Dostarlimab received within an interventional clinical trial

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 2 центра
  • ASL Napoli 1, Presidio Ospedaliero Ospedale del mare, Oncologia medica — Naples
  • IRCCS Fondazione G. Pascale, Unità Operativa Complessa Oncologia Addominale — Naples

Идентификаторы

NCT: NCT07269249 · RW-NEDOS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗