Chemoradiotherapy in Esophageal or Esophagogastric Junction Cancer

Официальное название

Cohort Study of Definitive Chemoradiotherapy for Esophageal or Esophagogastric Junction Cancer

Обзор

Definitive chemoradiotherapy is the standard of care in unresectable esophageal or esophagogastric cancer. A multidisciplinary approach, including chemotherapy and radiotherapy, is important for these patients. Morerover, molecular targeting agents does not show clear efficacy in EC up to now. Nowadays, the pace of development of cancer immunotherapies is accelerating. Clinical evidence of the efficacy of immune checkpoint inhibitors and adoptive immunotherapies herald the onset of a new era in cancer immunotherapy. There have also been recent developments to provide a promising frontier in extending the use of immunotherpay or targeting agents to radiotherapy. The purpose of this study was to explore the optimal treatment modalities including PD-1/PD-L1 antibody or targeted drug for patients with unresectable esophageal or esophagogastric junction cancer.

Вмешательства

• Лучевая терапия Radiotherapy
  50-66Gy/1.8-2.2Gy/25-30f
• Препарат Platinum based chemotherapy
  q1-3W according to physician's preference
• Препарат Paclitaxel based chemotherapy
  q1-3W according to physician's preference
• Препарат Immunotherapy
  Anti-PD-1/PD-L1 Antibody
• Препарат 5-FU Analog based chemotherapy
  W1-5 qW or d1-14, q3W according to physician's preference
• Препарат Nimotuzumab
  200-400mg, d1,qW

Первичные конечные точки

• Overall survival [Срок оценки: 1year]
• Overall survival [Срок оценки: 2 year]
• Overall survival [Срок оценки: 3 year]
• Overall survival [Срок оценки: 5 year]

Вторичные конечные точки (6)

• Progression free survival [Срок оценки: 1 year, 2 year, 3 year, 5 year]
• Number of participants with Acute and late toxicities of radiotherapy,chemotherapy and immunotherapy [Срок оценки: 3 months]
• Pathological response rate [Срок оценки: 3 months]
• R0 resection rate [Срок оценки: 3 months]
• Locoregional recurrence free survival [Срок оценки: 1 year, 2 year, 3 year, 5 year]
• Distant metastasis free survival [Срок оценки: 1 year, 2 year, 3 year, 5 year]

Критерии участия

Критерии включения

• ≥18 years；
• Esophageal or Esophagogastric cancer；
• Histologically proven squamous cell carcinoma or adenocarcinoma in patients staged as I-IVa(AJCC 8th)；
• Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences；
• ECOG PS score: 0\~1；
• Estimated survival time ≥3 months；
• Normal organ and marrow function as defined below:Hemoglobin: greater than or equal to 100g/L ;Leukocytes: greater than or equal to 4,000 G/L; Neutrophil: greater than or equal to 2,000 G/L; Platelets: greater than or equal to 100,000/mm3 ; Creatinine: less than or equal to 1.5 times the upper limit or CCR greater than or equal to 60 ml/min; AST/ALT: less than or equal to 2.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; INR: less than or equal to 1.5 times the upper limit; APTT: less than or equal to 1.5 times the upper limit; PT: less than or equal to 1.5 times the upper limit；
• Informed consent；

Критерии исключения

• With any distant metastasis out of regional lymphatic drainage or in liver, lung, bone, CNS, etc；
• Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer；
• Existing active infection such as active tuberculosis and hepatitis；
• History of myocardial infarction within the past 6 months or history of ventricular arrhythmia；
• Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness History of allergic reactions attributed to paclitaxel, albumin or cisplatin；
• Participation in other clinical trials currently or within 4 weeks of selection；
• Pregnant or lactating females；
• Absence of medical records.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 5 центров

• Department 4th of Radiation Oncology, Anyang Cancer Hospital — Anyang
• Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Centr — Чанша
• Department of Radiation oncology, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Rese — Нанкин
• Department of Radiation oncology, Jiangsu Province Hospital/The First Affiliated Hospital — Нанкин
• Department of Radiation Oncology, National Cancer Center/National Clinical Research Center — Пекин

Публикации

• Yang X, Wang X, Xiao Q, Ge X, Yu N, Li J, Feng G, Zheng Z, Jiang Y, Lu L, Xia X, Deng L, Zhang T, Wang W, Liu W, Wang J, Xiao Z, Zhou Z, Bi N, Wang H, Chen C, Wang X. Definitive chemoradiotherapy combined with anti-PD-1 immunotherapy for inoperable esophageal squamous cell carcinoma: a multicenter real-world study. Cancer Biol Ther. 2025 Dec;26(1):2504726. doi: 10.1080/15384047.2025.2504726. Epub PMID 40367097

Идентификаторы

NCT: NCT04821778 · NCC2722

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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