Cohort Study of Neoadjuvant Treatment Modalities for Esophageal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Esophageal cancer is the most prevalent cancer globally with poor survival outcome. The prognosis with surgery alone is poor, accounting for 30-40% of overall survival at 5 year. Either neoadjuvant chemotherapy (nCT) or chemoradiotherapy (nCRT) has been shown as efficatious therapy to improve patients outcomes in esophageal or esophagogastric junction cancer as compared with surgery alone. The purpose of this study was to explore the optimal neoadjuvant treatment modalities including PD-1/PD-L1 antibody or targeted drug for patients with 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
(Neoadjuvant chemotherapy) nCT
This arm received chemotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment.
干预措施: Platinum based chemotherapy (Drug)
(Neoadjuvant chemotherapy) nCT
This arm received chemotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment.
干预措施: Paclitaxel based chemotherapy (Drug)
(Neoadjuvant chemotherapy) nCT
This arm received chemotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment.
干预措施: Radiotherpay (Radiation)
(Neoadjuvant chemotherapy) nCT
This arm received chemotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment.
干预措施: Surgery (Procedure)
(Neoadjuvant chemotherapy) nCT
This arm received chemotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment.
干预措施: Immunotherapy (Drug)
(Neoadjuvant chemotherapy) nCT
This arm received chemotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment.
干预措施: 5-FU Analog based chemotherpay (Drug)
(Neoadjuvant chemotherapy) nCT
This arm received chemotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment.
干预措施: Nimotuzumab (Drug)
(Neoadjuvant Chemoradiation) nCRT
This arm received chemoradiotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment.
干预措施: Platinum based chemotherapy (Drug)
(Neoadjuvant Chemoradiation) nCRT
This arm received chemoradiotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment.
干预措施: Paclitaxel based chemotherapy (Drug)
(Neoadjuvant Chemoradiation) nCRT
This arm received chemoradiotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment.
干预措施: Surgery (Procedure)
(Neoadjuvant Chemoradiation) nCRT
This arm received chemoradiotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment.
干预措施: Immunotherapy (Drug)
(Neoadjuvant Chemoradiation) nCRT
This arm received chemoradiotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment.
干预措施: 5-FU Analog based chemotherpay (Drug)
(Neoadjuvant Chemoradiation) nCRT
This arm received chemoradiotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment.
干预措施: Nimotuzumab (Drug)
结局指标
主要结局
Overall survival
时间窗: 5 year
次要结局
- Number of participants with Acute and late toxicities of radiotherapy,chemotherapy and immunotherapy(3 months)
- Distant metastasis free survival(1 year, 2 year, 3 year, 5 year)
- Progression free survival(1 year, 2 year, 3 year, 5 year)
- Pathological response rate(3 months)
- R0 resection rate(3 months)
- Locoregional recurrence free survival(1 year, 2 year, 3 year, 5 year)
研究者
XIN WANG
Principal Investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences