Short-course Radiotherapy Combined With Sintilimab for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Pathological complete response
研究概览
简要总结
This study is aimed to evaluate the efficacy and safety of short-course radiotherapy combined with sintilimab in neoadjuvant treatment of stage III, locally advanced esophageal squamous cell carcinoma.
详细描述
This study was designed as a single arm, phase II trial. Subjects will receive short-course radiotherapy combined with sintilimab as neoadjuvant therapy of stage III, locally advanced esophageal squamous cell carcinoma. The primary endpoint is pathologic complete response(pCR).
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 years old and ≤75 years old
- •Esophageal squamous cell carcinoma diagnosed biopsy histopathology
- •Patients with resectable esophageal squamous cell carcinoma confirmed by pathology (including histology or cytology) , with pathological stage T3-4 or N+
- •At least one measurable lesion
- •Eastern cooperative oncology group (ECOG) performance status of 0 to 1
- •With adequate organs function
排除标准
- •Patients with active malignancy within 5 years other than the tumor studied in this study or a localized tumor that has been cured such as resected basal or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or breast cancer
- •Patients who have a higher risk of bleeding or perforation due to the tumor's obvious invasion of the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed a fistula
- •Patients who have received any anti-tumor therapy for the research disease in the past, including radiotherapy, chemotherapy, immunotherapy (including but not limited to interleukin, interferon, thymus hormone) and traditional Chinese medicine therapy
研究组 & 干预措施
short-course radiotherapy+sintilimab
干预措施: sintilimab，programmed death 1 monoclonal antibody (Drug)
结局指标
主要结局
Pathological complete response
时间窗: 4 weeks after surgery
Total tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
Incidence rate of adverse events
时间窗: 3 years
The ratio of the number of cases with adverse events to the total number of cases available for evaluation.
次要结局
- overall survival(3 years)
- Disease-free survival(3 years)