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Набор скоро начнётся NCT07697898

TDLN-Guided Lymphadenectomy After Neoadjuvant Immunochemotherapy for ESCC

— Наблюдательное Esophageal Squamous Cell Carcinoma (ESCC)

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: Curative Esophagectomy With Systematic Lymphadenectomy.
Кому может быть актуально
Состояния в реестре: Esophageal Squamous Cell Carcinoma (ESCC). Базовые параметры: 18 лет — 75 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Tumor-Draining Lymph Node Preservation-Guided Intraoperative Lymphadenectomy After Neoadjuvant Immunochemotherapy for Esophageal Squamous Cell Carcinoma: A Prospective Multicenter Observational Cohort Study

Обзор

This is a prospective, multicenter, observational cohort study of patients with esophageal squamous cell carcinoma who have received neoadjuvant immunochemotherapy and are scheduled to undergo curative esophagectomy with standard systematic lymphadenectomy. The study will not alter the current standard surgical approach. All patients will receive curative esophagectomy and systematic lymph node dissection according to institutional practice. Lymph nodes will be separated and recorded by anatomical station during surgery, followed by station-level pathological assessment. Imaging findings, pathological response, perioperative outcomes, recurrence patterns, disease-free survival, overall survival, and selected immune microenvironment features will be collected and analyzed. The purpose of this study is to characterize station-level residual lymph node metastasis risk and immune activity after neoadjuvant immunochemotherapy. The findings may help identify candidate lymph node stations for future research on individualized or lymph node-preserving surgical strategies in esophageal squamous cell carcinoma.

Вмешательства

  • Процедура Curative Esophagectomy With Systematic Lymphadenectomy
    All participants will undergo curative esophagectomy with standard systematic lymphadenectomy according to institutional practice. The study will not intentionally reduce the extent of lymph node dissection. Lymph nodes will be separated, labeled, and recorded by anatomical station for postoperative pathological and exploratory immune microenvironment analyses.

Первичные конечные точки

  • 2-Year Disease-Free Survival Rate [Срок оценки: 24 months after curative esophagectomy]
Вторичные конечные точки (5)
  • Overall Survival [Срок оценки: Up to 24 months after curative esophagectomy]
  • 2-Year Overall Survival Rate [Срок оценки: 24 months after curative esophagectomy]
  • Locoregional Recurrence Rate [Срок оценки: Up to 24 months after curative esophagectomy]
  • Distant Metastasis Rate [Срок оценки: Up to 24 months after curative esophagectomy]
  • Pattern of First Failure [Срок оценки: Up to 24 months after curative esophagectomy]

Критерии участия

Критерии включения

  • Age 18 to 75 years, regardless of sex.
  • Eastern Cooperative Oncology Group performance status of 0 to 1.
  • Histologically confirmed thoracic esophageal squamous cell carcinoma.
  • Received neoadjuvant immunochemotherapy and considered suitable for curative surgery after multidisciplinary team evaluation.
  • Clinically resectable locally advanced or locally progressive disease without evidence of distant metastasis.
  • Completed preoperative contrast-enhanced computed tomography of the neck, chest, and abdomen. Positron emission tomography-computed tomography and/or endoscopic ultrasound may be performed if clinically available.
  • Considered by the investigator to be able to tolerate curative esophagectomy and standard systematic lymphadenectomy.

Критерии исключения

  • Non-squamous cell carcinoma histology or concurrent primary malignancy requiring treatment.
  • Previous curative surgery for esophageal cancer or previous radiotherapy for the current esophageal lesion.
  • Evidence of distant metastasis, unresectable disease, or considered unsuitable for curative surgery after multidisciplinary team evaluation.
  • Severe autoimmune disease requiring long-term systemic immunosuppressive therapy.
  • Severe cardiac, pulmonary, hepatic, renal, or other major organ dysfunction that prevents surgery or completion of study-related assessments.
  • Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study, including poor compliance, inability to complete scheduled follow-up, or inability to provide key study data.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07697898 · TJ-IRB202606005

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗