Postoperative Radiotherapy Followed by Immunotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma: A Phase II Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 1-year disease-free survival
研究概览
简要总结
Esophageal squamous cell carcinoma is a common malignancy in China. Although neoadjuvant chemoradiotherapy followed by esophagectomy remains a standard modality for locally advanced esophageal squamous cell carcinoma, esophagectomy followed by postoperative radiotherapy is also prevalent in China. Several retrospective studies demonstrated that postoperative radiotherapy could improve the prognosis of patients. Nevertheless, there still existed approximately 11.5% and 17.2% of total patients developing local-regional relapse and hematological metastasis. The result of Checkmate 577 has shown that postoperative immunotherapy of nivolumab could improve the disease-free survival (median Disease-free Survival 29.7 mos vs. 11.0 mos). Therefore, investigators aimed to implement a pilot study to explore the safety and efficacy of combining postoperative radiotherapy and immunotherapy for patients with locally advanced esophageal squamous cell carcinoma after esophagectomy.
详细描述
Trial Title: Postoperative radiotherapy followed by immunotherapy for locally advanced esophageal squamous cell carcinoma: A pilot study Trial Objective: To explore the safety and efficacy of combining postoperative radiotherapy and immunotherapy for patients with locally advanced esophageal squamous cell carcinoma after esophagectomy.
Trial Design: To enroll 70 patients with locally advanced esophageal squamous cell carcinoma who would be randomly assigned to experimental arm (esophagectomy followed by postoperative radiotherapy with immunotherapy) and controlled arm (esophagectomy followed by postoperative radiotherapy).
Inclusion Criteria: a. 18-75 years old. b. after esophagectomy. c. confirmation of squamous cell carcinoma by pathological examination. d. pathological staging of pIIb-IVa. e. over 12 lymph nodes dissected during surgery. f. ECOG 0-1. g. signature of inform consent by patients Exclusion Criteria: a. younger than 18 years old or older than 75 years old. b. without esophagectomy. c. non-squamous cell carcinoma. d. pathological staging of pI, IIa, IVb. e. less than 12 lymph nodes dissected during surgery. f. ECOG 2-3 g. no signature of inform consent.
Esophagectomy: Mckeown or Ivor-Lewis surgery
Staging Examination before Postoperative Radiotherapy: a. ECOG scoring. b. PET-CT (preferred), or chest contrast CT, abdominal ultrasonography and bone scan. c. PD-L1 expression level of surgical specimen. d. NRS2002 and PG-SGS scoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old.
- •After esophagectomy.
- •Confirmation of squamous cell carcinoma by pathological examination.
- •Pathological staging of pIIb-IVa.
- •Over 12 lymph nodes dissected during surgery.
- •Signature of inform consent by patients
排除标准
- •Younger than 18 years old or older than 75 years old.
- •Without esophagectomy.
- •Non-squamous cell carcinoma.
- •Pathological staging of pI, IIa, IVb.
- •Less than 12 lymph nodes dissected during surgery.
- •ECOG 2-3 g. no signature of inform consent.
研究组 & 干预措施
Experimental Arm
Esophagectomy+postoperative radiotherapy+immunotherapy
干预措施: Immune Checkpoint Inhibitors (Drug)
Controlled Arm
Esophagectomy+postoperative radiotherapy
干预措施: Immune Checkpoint Inhibitors (Drug)
结局指标
主要结局
1-year disease-free survival
时间窗: 1 year
1-year disease-free survival
次要结局
- Rate of irradiation-induced or immune-induced pneumonitis(1 year)
- 3-year disease-free survival(3 year)
- 3-year overall survival(3 year)
研究者
Dong Qian
Professor
Anhui Provincial Hospital