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Идёт набор NCT07566559

Rectal Cancer Neoadjuvant Therapy-Real World Study

— Наблюдательное Rectal Cancer

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: This study is a multicenter, real-world, non-interventional study..
Кому может быть актуально
Состояния в реестре: Rectal Cancer. 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
Китай
Следующий шаг
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Официальное название

Establishing a Strategy for Selecting Watchful Waiting and Determining the Optimal Timing for Surgery Following Neoadjuvant Therapy

Обзор

This study aims to utilise a real-world data platform to integrate multi-omics data-including radiomics, gut microbiota, pathological quality control and liquid biopsy-to construct a multidimensional predictive model for the efficacy of rectal cancer treatment following neoadjuvant therapy. By integrating multimodal data, the study aims to accurately assess the efficacy of neoadjuvant therapy and identify patients suitable for a 'watch-and-wait' strategy, thereby achieving tumour control and preserving organ function without the need for surgery. Furthermore, it seeks to provide scientific evidence for the efficacy of the 'watch-and-wait' strategy and the selection of optimal timing for surgery, whilst validating the model's effectiveness and assessing its clinical feasibility through prospective clinical trials.

Подробное описание

1. Optimisation and predictive modelling of immunotherapy combined with neoadjuvant chemoradiotherapy Through real-world studies, we will evaluate the efficacy and safety of immunotherapy combined with neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer, focusing on comparing outcomes with traditional chemoradiotherapy regimens to optimise neoadjuvant treatment protocols. By integrating radiomics and molecular subtyping data, we will develop a deep learning model to predict the rate of pathological complete response, thereby accurately forecasting treatment outcomes for patients. This model can further optimise personalised treatment decisions, enhance the effectiveness of organ-preservation strategies, and ultimately reduce surgical trauma for patients. 2. A Treatment Efficacy Assessment System Combining Multi-omics Data with Artificial Intelligence Integrate multi-omics data (such as molecular subtyping, radiomics, and pathological assessment) with artificial intelligence technology to establish a treatment efficacy assessment system. Utilise deep learning models to analyse pre- and post-treatment imaging data and pathological samples, thereby achieving precise efficacy assessment.

Вмешательства

  • Другое This study is a multicenter, real-world, non-interventional study.
    non-interventional study

Первичные конечные точки

  • To compare the complete response rates across different treatments. [Срок оценки: Post-neoadjuvant Therapy Efficacy Assessment Time Point (within 8-12 weeks after radiotherapy completion)]
Вторичные конечные точки (3)
  • Safety profile [Срок оценки: 20 weeks after the first radiotherapy session]
  • Therapy Tolerability [Срок оценки: 20 weeks after the first radiotherapy session]
  • Disease-Free Survival (DFS) [Срок оценки: within 5 years after completion of neoadjuvant therapy]

Критерии участия

Критерии включения

  • The patient is informed and has provided written informed consent;
  • Rectal adenocarcinoma confirmed by colonoscopic biopsy and pathology, meeting the following criteria:
  • Clinical stage II/III locally advanced rectal cancer (LARC): cT1-4aN0-2M0;
  • The distal edge of the tumor is ≤ 10 cm from the anal verge (measured by MRI);
  • No distant metastasis;
  • Scheduled to receive neoadjuvant therapy;
  • Age ≥ 18 years, male or female。

Критерии исключения

  • Presence of distant organ metastasis;
  • Multiple primary colorectal cancers;
  • History of prior malignancy (except completely cured carcinoma in situ of the cervix, basal cell carcinoma, or squamous cell carcinoma of the skin).

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Китай · 1 центр
  • Beijing Friendship Hospital — Пекин

Идентификаторы

NCT: NCT07566559 · MR-11-26-025202 · MR-11-26-025202

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗