Neoadjuvant Chemoradiotherapy Combined With Camrelizumab and Nimotuzumab for Initially Inoperable Patients With Locally Advanced Esophageal Squamous Cell Carcinoma: A Prospective, One-arm, Phase II Study (NCRCN)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- 1-year progression free survival (PFS) rate
研究概览
简要总结
Neoadjuvant chemoradiotherapy followed by surgery has been the standard modality for locally advance esophageal carcinoma. According to CROSS study, the pathological complete remission rate achieved by paclitaxel and carboplatin with 41.4 Gy/23f was 49% for esophageal squamous cell carcinoma. But the 10-year overall survival rate was only 38%. How to increase the overall survival of esophageal carcinoma is a pivotal task. Both of Camrelizumab and Nimotuzumab have been demonstrated to be efficacious in the neoadjuvant treatment for esophageal squamous cell carcinoma in some small sample-size trials. Therefore, this trial is designed to combine adjuvant chemoradiotherapy with Camrelizumab and Nimotuzumab for resectable & potentially resectable locally advanced esophageal squamous cell carcinoma and explore the safety and primary efficacy of such combination.
详细描述
Trial Title Neoadjuvant chemoradiotherapy combined with Camrelizumab and Nimotuzumab for initially inoperable patients with locally advanced esophageal squamous cell carcinoma: A Prospective, One-arm, Phase II study (NCRCN) Trial Objective To explore the safety and primary efficacy of neoadjuvant chemoradiotherapy combined with Camrelizumab and Nimotuzumab for initially inoperable patients with locally advanced esophageal squamous cell carcinoma.
Trial Design: To enroll 35 patients with initially inoperable patients with locally advanced esophageal squamous cell carcinoma to receive neoadjuvant chemoradiotherapy combined with Camrelizumab and Nimotuzumab followed by surgery.
Staging Examination before Adjuvant Treatment: a. ECOG scoring. b. PET-CT, Upper GI endoscopy & endoscopic ultrasound and barium swallow (preferred), or chest contrast CT, abdominal ultrasonography, bone scan, Upper GI endoscopy & endoscopic ultrasound and barium swallow. c. Bronchoscopy for patients with suspicious invasion into trachea or bronchus. d. Pulmonary function test.
Adjuvant chemoradiotherapy Radiotherapy CT Simulation: CT with intravenous contrast is recommended for simulation. Scan thickness should be less than 5 mm from lower margin of mandibular to lower margin of L2. Thermal mask is recommended.
Delineation of Targets: Involved field irradiation is the general principle. Gross Tumor Volume (GTV) is the primary esophageal tumor and the metastatic lymph node. The Clinical Target Volume (CTV) provided a proximal and distal margin of 3 cm and a 0.8 cm radial margin around the primary esophageal tumor and a proximal and distal margin of 1 cm and a 0.8 cm radial margin around the metastatic lymph nodes. The Planning Target Volume (PTV) was defined as an 8-mm margin of the CTV for tumor motion and set-up variations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old;
- •Eastern Cooperative Oncology Group (ECOG) 0-1;
- •Esophageal squamous cell carcinoma;
- •cT2-4aN0-3M0-1a (AJCC 8th) confirmed by radiological examination;
- •Initially inoperable at initial diagnosis confirmed by thoracic surgeons;
- •No esophageal hemorrhage and no esophageal fistula at initial diagnosis;
- •Treatment naive;
- •No contraindications for adjuvant chemoradiotherapy, camrelizumab and nimotuzumab;
- •Signature of inform consent.
排除标准
- •younger than 18 years old or older than 75 years old;
- •Esophageal adenocarcinoma, small-cell cancer and other pathological types;
- •Presence of esophageal hemorrhage and esophageal fistula at initial diagnosis;
- •Previous treatment of chemotherapy, radiotherapy, immune therapy and other treatment;
- •Contraindications for chemoradiotherapy, camrelizumab and nimotuzumab;
- •No signature of inform consent.
研究组 & 干预措施
Neoadjuvant treatment
Neoadjuvant chemoradiotherapy combined with Camrelizumab and Nimotuzumab
干预措施: neoadjuvant chemoradiotherapy combined with Camrelizumab and Nimotuzumab followed by surgery (Drug)
结局指标
主要结局
1-year progression free survival (PFS) rate
时间窗: 0 month post neoadjuvant treatment
1-year progression free survival (PFS) rate
次要结局
- Rate of adverse events(1 to 2years)
- Pathological complete remission rate(0 month post surgery)
- 1-, 2-year overall survival rate .(1 to 2years)
- Major pathological remission rate(0 month post surgery)
- surgical conversion rate(0 month post neoadjuvant)
研究者
Dong Qian
Professor
Anhui Provincial Hospital