Меню
Набор скоро начнётся NCT07656740

Non-Operative Management and Following Immunotherapy for Colorectal Cancer and Other GI Cancers

— Наблюдательное Gastrointestinal Cancer Colorectal (Colon or Rectal) Cancer Stomach (Gastric) 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: NOM, RO.
Кому может быть актуально
Состояния в реестре: Gastrointestinal Cancer, Colorectal (Colon or Rectal) Cancer, Stomach (Gastric) 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Non-Operative Management and Following Immunotherapy for Colorectal Cancer and Other GI Cancers (NOMIC Trial)

Обзор

This is a single-center, bidirectional (retrospective and prospective) registry study aimed at evaluating the safety and efficacy of Non-Operative Management (NOM) and Organ-Preserving Functional Surgery (OPFS) in patients with mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) or POLE-mutated gastrointestinal (GI) cancers who received neoadjuvant immunotherapy.Patients achieving a clinical complete response (cCR) or near-cCR may undergo a "Watch \& Wait" (W\&W) strategy, while those with near-cCR or non-cCR ($\\le ymrT2N0$) may undergo local excision (LE) or endoscopic resection (ESD/EMR). Patients undergoing radical operation (RO) will serve as the control cohort to compare oncological outcomes and safety data.

Вмешательства

  • Другое NOM
    Patients achieving a clinical complete response (cCR) or near-cCR may undergo a "Watch \& Wait" (W\&W) strategy, while those with near-cCR or non-cCR (≤ymrT2N0) may undergo local excision (LE) or endoscopic resection (ESD/EMR).
  • Другое RO
    Patients undergoing radical operation (RO) will serve as the control cohort to compare oncological outcomes and safety data.

Первичные конечные точки

  • Organ Preservation Rate [Срок оценки: 3 years after the completion of neoadjuvant immunotherapy.]
Вторичные конечные точки (5)
  • Surgical Safety and Postoperative Complications [Срок оценки: 3 years after the completion of neoadjuvant immunotherapy.]
  • Distribution of Pathological Response (RO Group Only) [Срок оценки: At the time of radical surgery (typically 4-12 weeks post-immunotherapy).]
  • Local Regrowth Rate [Срок оценки: Regular follow-up every 3-6 months for up to 3 years.]
  • Overall Survival (OS) [Срок оценки: Up to 5 years.]
  • Disease-Free Survival (DFS) [Срок оценки: Up to 5 years from enrollment/treatment initiation.]

Критерии участия

Критерии включения

  • Retrospective Cohort Inclusion Criteria
  • Pathologically confirmed gastrointestinal malignancy determined as MSI-H/dMMR or POLE mutation, and initially resectable.
  • Completed prior immunotherapy.
  • No evidence of distant metastasis.
  • Managed with W\&W, LE, endoscopic surgery, or radical operation after treatment.
  • Prospective Cohort Inclusion Criteria
  • Pathologically confirmed gastrointestinal malignancy determined as MSI-H/dMMR or POLE mutation, and initially resectable.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Immunotherapy status: naive, currently receiving, or completed treatment, and evaluated by the PKUCH-NOMIC research group as cCR/near-cCR or Non-cCR (≤ ymrT2N0).
  • No evidence of distant metastasis.
  • Absence of emergencies requiring immediate surgery (e.g., hemorrhage, perforation, obstruction).

Критерии исключения

  • Recurrent gastrointestinal tumors.Initial presence of unresectable distant metastases.
  • Serum creatinine > 1.5 times upper limit of normal (ULN).
  • History of pelvic radiation therapy.Inability to tolerate MRI examinations.
  • History of other malignancies within the past 5 years with a survival rate significantly lower than the historical rectal cancer survival data of this center (except adequately treated basal cell carcinoma, cutaneous squamous cell carcinoma, small renal cell carcinoma, breast cancer, and papillary thyroid carcinoma).
  • Arterial thromboembolic events within the past 6 months (e.g., angina, myocardial infarction, transient ischemic attack \[TIA\], cerebral vascular accident \[CVA\]).
  • Prior receipt of other types of investigational anti-tumor therapies.
  • Pregnant or lactating women.
  • Concomitant diseases or mental health conditions that may interfere with study participation.

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 · 1 центр
  • Peking University Cancer Hospital — Пекин

Идентификаторы

NCT: NCT07656740 · NOMIC Trial

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗