A Prospective, Single-arm, Single-center, Exploratory Study of the Safety and Efficacy of Serplulimab Combined With Chemotherapy in Patients With Resectable Esophageal Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Pathological Complete Response (PCR)
研究概览
简要总结
China with high incidence of esophageal cancer, the number of new cases and deaths account for about 50% of the world every year. In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of esophageal squamous cell carcinoma patients was not significantly decreased. For patients with locally advanced esophageal cancer, direct surgery is not effective. It is difficult to achieve radical resection by surgery merely, and even if many patients receive surgery, they may eventually have tumor recurrence and poor survival rate. Therefore, it is necessary to explore effective perioperative neoadjuvant treatment to reduce the risk of postoperative recurrence and improve the postoperative survival rate of patients. According to the reports, the expression of PD-L1 in esophageal cancer was about 41.4%. Therefore, PD-1/ PD-L1 immunocheckpoint inhibitor may become a new method for the treatment of esophageal cancer. Preliminary clinical results showed that immunotherapy combined with chemoradiotherapy provided a synergies antitumor effect. Multiple clinical results showed that serplulimab provided higher overall response rate for advanced esophageal cancer. However, in patients with locally advanced esophageal cancer, the efficacy of serplulimab combined with chemotherapy for sequential radical surgery is still unclear. The purpose of this study is to observe and evaluate the efficacy and safety of silulimab combined with chemotherapy in the neoadjuvant therapy of resectable esophageal squamous cell carcinoma.
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
- •signed informed consent;
- •patients age 18 to 75 years old
- •primary resectable, histologically confirmed esophageal squamous cell cancer;
- •Esophageal squamous cell carcinoma the clinical stage was IIA-IVA (according to AJCC TNM stage, 8th edition).
- •No distant metastasis, the diseases could be resectable assessed by thoracic oncologist;
排除标准
- •with significant cardiovascular disease;
- •current treatment with anti-viral therapy or HBV;
- •Female patients who are pregnant or lactating;
- •history of malignancy within 5 years prior to screening;
- •active or history of autoimmune disease or immune deficiency;
- •signs of distant metastases.
结局指标
主要结局
Pathological Complete Response (PCR)
时间窗: 1 month after surgery
No residual invasive tumor cells were found in the pathological examination of resected specimens, including the primary tumor and lymph nodes.
次要结局
- Objective Response Rate (ORR)(before surgery)
- major pathological response (MPR)(1 month after surgery)
- 2-year and 5-year overall survival(2-year and 5-year after surgery)
- R0 resection rate(1 month after surgery)
- Incidence of Treatment-related Adverse Events(1 month after surgery)
- The changes in the peripheral blood immunoprofile and tumor tissue sample among non-PCR (NPCR) and PCR patients(3 months after surgery)