NCT04821778招募中3 期

Cohort Study of Definitive Chemoradiotherapy for Esophageal or Esophagogastric Junction Cancer

Cancer Institute and Hospital, Chinese Academy of Medical Sciences5 个研究点分布在 1 个国家目标入组 2,000 人开始时间: 2002年1月1日最近更新: 2026年1月21日

适应症

干预措施

试验速览

阶段: 3 期
状态: 招募中
发起方: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
入组人数: 2,000
试验地点: 5
主要终点: Overall survival

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•≥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；

排除标准

•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.

研究组 & 干预措施

Definitive Chemoradiation

Placebo Comparator

This arm received chemoradiation without immunotherapy/targeting agents as definitive treatment.

干预措施: Radiotherapy (Radiation)

Definitive Chemoradiation

Placebo Comparator

This arm received chemoradiation without immunotherapy/targeting agents as definitive treatment.

干预措施: Platinum based chemotherapy (Drug)

Definitive Chemoradiation

Placebo Comparator

This arm received chemoradiation without immunotherapy/targeting agents as definitive treatment.

干预措施: Paclitaxel based chemotherapy (Drug)

Definitive Chemoradiation

Placebo Comparator

This arm received chemoradiation without immunotherapy/targeting agents as definitive treatment.

干预措施: 5-FU Analog based chemotherapy (Drug)