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Идёт набор NCT07381322

A Study on the Accurate Evaluation of Pseudoprogression of Rectal Cancer Immunotherapy Based on Multitemporal and Multiparameter MRI

— 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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Rectal Cancer. Базовые параметры: Без ограничений · 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This project aims to use multi-temporal, multi-parameter MRI features, blood biomarkers, and clinical indicators to accurately assess pseudoprogression following immunotherapy in rectal cancer.

Первичные конечные точки

  • The area under curve (AUC) of receive operating characteristic (ROC) curves of models in prediction pseudoprogression after rectal cancer immunotherapy [Срок оценки: From date of baseline MRI to date of preoperative MRI]
Вторичные конечные точки (7)
  • The specificity of models in prediction pseudoprogression [Срок оценки: From date of baseline MRI to date of preoperative MRI]
  • The sensitivity of models in prediction pseudoprogression [Срок оценки: From date of baseline MRI to date of preoperative MRI]
  • The positive predictive value of models in prediction pseudoprogression [Срок оценки: From date of baseline MRI to date of preoperative MRI]
  • The negative predictive value of models in prediction pseudoprogression [Срок оценки: From date of baseline MRI to date of preoperative MRI]
  • The accuracy of models in prediction pseudoprogression [Срок оценки: From date of baseline MRI to date of preoperative MRI]
  • Disease-free survival and overall survival [Срок оценки: From date of enrollement until the date of first documented progression or date of death from any cause,whichever came first,assessed up to 60 months]
  • patients are divided into: iCPD patients are classified as the 'tumor progression group after immunotherapy,' while iCR, iPR, and iSD patients are classified as the 'non-tumor progression group after immunotherapy. [Срок оценки: From date of enrollement until the date of first documented progression or date of death from any cause,whichever came first,assessed up to 60 months]

Критерии участия

Критерии включения

  • Rectal cancer confirmed by biopsy pathology;
  • Clinical stage II-IV determined by imaging examinations;
  • Decided by the MDT team to receive immunotherapy (monotherapy with PD-1/PD-L1 inhibitors or in combination with CTLA-4 inhibitors), without prior treatment of any other kind;
  • Multiparametric MRI images of the rectum obtained within 2 weeks before immunotherapy, and at 6 and 12 weeks after treatment;
  • Follow-up CT/MRI data available; evaluation conducted according to the iRECEST criteria, or surgical resection performed to obtain postoperative pathological results, which are necessary for assessing the efficacy of immunotherapy and diagnosing pseudoprogression versus true progression;
  • Blood test parameters (IL-8, NLR, LDH, S100) and clinical indicators (KPS score, CEA level, T-stage) measured within 2 weeks before immunotherapy, and at 6 and 12 weeks after treatment;
  • In cases where imaging suggests disease progression, pathological biopsy or surgical pathology results must be available.
  • The overall survival period is more than 3 months, and the patient does not have any other uncontrollable diseases;
  • The patient has been fully informed and has signed the informed consent form.

Критерии исключения

  • The primary tumor lesion has been surgically removed at the time of initial diagnosis;
  • History of other malignant tumors;
  • Unable to sign informed consent or complete the trial due to physical or psychological illness;
  • Pregnant or lactating women;
  • Those who are allergic to gadolinium-containing contrast agents or contraindicated to undergo enhanced MRI examination, or those who are claustrophobic or have other contraindications to MRI examination and cannot undergo MRI examination;
  • History of autoimmune diseases such as inflammatory bowel disease;
  • Treatment interruption due to serious complications related to immunotherapy.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 2 центра
  • Sixth affiliated hospital, Sun Yat-sen University — Гуанчжоу
  • Xinyi People's hospital — Maoming

Идентификаторы

NCT: NCT07381322 · 2026ZSLYEC-028

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗