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临床试验/NCT07269249
NCT07269249招募中不适用

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

National Cancer Institute, Naples2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年9月1日最近更新:
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干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
2
主要终点
Objective response rate (ORR)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.
  1. 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.
  2. 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)

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

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

研究组 & 干预措施

Stage II-III rectal cancer (LARC)

patients with dMMR/MSI LARC treated with neoadjuvant dostarlimab

干预措施: Dostarlimab (Drug)

结局指标

主要结局

Objective response rate (ORR)

时间窗: after 3 , 6 and 9 cycles of dostarlimab. Each cycle is 21 days. Up to 6 months

Defined as the percentage of trial participants having a CR or PR, as per RECIST v1.1.

次要结局

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

研究者

发起方
National Cancer Institute, Naples
申办方类型
Other
责任方
Sponsor

研究点 (2)

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