The Safety and Efficacy of Tislelizumab in Combination With Chemotherapy for Conversion Therapy of Locally Nonresectable ESCC，A Single-arm Study
试验速览
- 阶段
- 2 期
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Incidence of translational treatment AE
研究概览
简要总结
This is a single-arm，open-label study to evaluate the efficacy and safety of tislelizumab plus chemotherapy for conversion therapy of patients with locally nonresectable ESCC.
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
- 是
入选标准
- •Aged between 18 and 75 years;
- •Understand the research procedure and content, and voluntarily sign written informed consent;
- •Patients with clinical stage IIA-IIIB esophageal cancer were assessed by endoscopic ultrasonography, CT/MRI and other imaging.
- •Esophageal surgery experts believe that patients with potentially resectable esophageal cancer
- •No blood transfusion was received 3 months before enrollment;
- •ECOG PS score: 0-1.
排除标准
- •Patients meeting any of the following criteria are not eligible for inclusion:
- •Women who are pregnant or breastfeeding;
- •previous or concurrent malignancy;
- •Participated in clinical trials of other drugs within four weeks;
- •Have a history of immune deficiency, or other acquired or congenital immune deficiency diseases, or have a history of organ transplantation, or have a history of serious chronic autoimmune diseases, such as systemic lupus erythematosus, etc.
- •Patients with hypersensitivity to human or mouse monoclonal antibodies;
- •Those who have a history of psychotropic drug abuse and cannot get rid of it or have mental disorders;
- •According to the judgment of the researcher, there are serious concomitant diseases that endanger the patient's safety or affect the patient's ability to complete the study.
研究组 & 干预措施
Tislelizumab plus Chemotherapy
In the single experimental arm, patients with locally nonresectable disease were subjected to receive neoadjuvant tislelizumab (200mg) plus chemotherapy (FP regimen) for conversion therapy. If conversion therapy succeeds, patients would proceed to surgery and adjuvant therapy. Otherwise, if patients were still not resectable after the conversion therapy, they will be treated by tislelizumab plus chemotherapy with or without palliative radiotherapy .
干预措施: Tislelizumab (Drug)
Tislelizumab plus Chemotherapy
In the single experimental arm, patients with locally nonresectable disease were subjected to receive neoadjuvant tislelizumab (200mg) plus chemotherapy (FP regimen) for conversion therapy. If conversion therapy succeeds, patients would proceed to surgery and adjuvant therapy. Otherwise, if patients were still not resectable after the conversion therapy, they will be treated by tislelizumab plus chemotherapy with or without palliative radiotherapy .
干预措施: 5-FU (Drug)
Tislelizumab plus Chemotherapy
In the single experimental arm, patients with locally nonresectable disease were subjected to receive neoadjuvant tislelizumab (200mg) plus chemotherapy (FP regimen) for conversion therapy. If conversion therapy succeeds, patients would proceed to surgery and adjuvant therapy. Otherwise, if patients were still not resectable after the conversion therapy, they will be treated by tislelizumab plus chemotherapy with or without palliative radiotherapy .
干预措施: cis Platinum (Drug)
结局指标
主要结局
Incidence of translational treatment AE
时间窗: up to 2 years
Translational treatment-related AEs resulted in rates of surgery that were more than 30 days late or inoperable than originally planned
MPR
时间窗: up to 2 years
The proportion of patients whose primary tumor cell residual was less than 10% in the total number of patients enrolled after transformation therapy
pCR
时间窗: up to 2 years
Pathological complete response refers to that no tumor component or a small amount of carcinoma in situ component can be found on the horizontal line of pathological section after systemic treatment and surgical resection of the lesion.
次要结局
- Disease-free Survival，DFS(up to 2 years)
- R0 resection rate(up to 2 years)