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Идёт набор NCT06907602

Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma

Фаза II / Фаза III С лечением Locally Advanced Esophageal Squamous Cell Carcinoma

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: Chemotherapy, Immunotherapy (Pembrolizumab), radiotherapy.
Кому может быть актуально
Состояния в реестре: Locally Advanced Esophageal Squamous Cell Carcinoma. 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

Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma: A Phase II Clinical Study

Обзор

Our previous study, a single-center, prospective, single-arm Phase II study (Keypoint001) has demonstrated the efficacy and safety of neoadjuvant chemotherapy combined with immunotherapy in locally advanced (cT3-4N+M0) esophageal squamous cell carcinoma. The results show that the pathological complete response rate (pCR) reaches 35%, and the major pathological response rate is over 70%, which is much higher than that of patients receiving chemotherapy alone. Meanwhile, no severe adverse drug reactions have been found in terms of safety, so this treatment regimen is safe and reliable. However, the cycle of neoadjuvant immunotherapy is still under exploration. Currently, the mainstream research centers adopt a regimen of 2 to 4 cycles. The exploration results of our center have found that most patients' conditions can be further alleviated after 4 cycles compared with after 2 cycles, but there are still a small number of patients with no obvious remission. Therefore, we consider observing whether patients with no obvious remission can achieve a better pathological response rate through further radiotherapy.

Вмешательства

  • Препарат Chemotherapy
    carboplatin plus nab-paclitaxel
  • Препарат Immunotherapy (Pembrolizumab)
    Pembrolizumab
  • Лучевая терапия radiotherapy
    40-45Gy/20fx，5 times a week

Первичные конечные точки

  • Pathological response [Срок оценки: After surgery]
  • 2-year and 5-year overall survival [Срок оценки: 2 years and 5 years after therapy]
Вторичные конечные точки (4)
  • Adverse effect incidence [Срок оценки: 1 years after therapy]
  • R0 resection rate [Срок оценки: After surgery]
  • postoperative complications [Срок оценки: After surgery]
  • 2-year and 5-year disease-free survival [Срок оценки: 2 years and 5 years after therapy]

Критерии участия

Критерии включения

  • male or female
  • Age ≥ 18 years old
  • Pathological confirmation of esophageal squamous cell carcinoma
  • Endoscopic ultrasound, enhanced CT scan of the neck, chest, and abdomen, and esophageal magnetic resonance imaging evaluate as T3 or resectable T4 PET/CT、 Cervical, thoracic, and abdominal enhanced CT evaluation of N0 or N+
  • No clear distant metastasis (M0) and only cervical or supraclavicular lymph node metastasis (M1a)
  • Tumor longitudinal diameter ≤ 10cm
  • The tumor did not involve the dentate line
  • ECOG score 0 or 1
  • No hematological diseases, no liver or kidney dysfunction
  • Absolute neutrophil count ≥ 1.5 × 109/L
  • Platelets ≥ 100 × 109/L
  • Hemoglobin ≥ 11g/L
  • ALT ≤ 2 times the upper limit of normal value
  • TBil ≤ 1.5 times the upper limit of normal value
  • Creatinine clearance rate (Cockroft) ≥ 50ml/min
  • Obtain informed consent

Критерии исключения

  • T staging evaluation is T1/T2
  • PET/CT and other evaluations show distant metastasis (M1)
  • Planned pregnancy or patients during pregnancy or lactation
  • History of previous chemotherapy, radiation therapy, or immunotherapy
  • Previous severe coronary heart disease and heart failure (NYHA grade III/IV)
  • Previous pulmonary interstitial fibrosis or severe pulmonary dysfunction that cannot tolerate surgery
  • Previous autoimmune disease requiring systemic treatment within 2 years
  • Previous immunodeficiency diseases or the need for systemic steroid replacement therapy
  • Previous motor or sensory neurotoxic diseases
  • Previous mental illness
  • Potential diseases that may affect patients' ability to receive planned treatment, such as drug allergies
  • Acute infectious diseases requiring systemic treatment
  • Previous HIV, HBV, or HCV infections
  • Previously received stem cell or solid organ transplantation

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Peking Union Medical College Hospital — Пекин

Идентификаторы

NCT: NCT06907602 · Keypoint 002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗