Neoadjuvant Tislelizumab Combined With Chemoradiotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma : Single Arm Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Major Pathological Response Rate
研究概览
简要总结
This study aimed to evaluate the safety and feasibility of neoadjuvant tislelizumab combined with chemoradiotherapy in patients with resectable esophageal squamous cell cancer. The tumor microenvironment and circulating immunological biomarkers in these patients were further evaluated to explore the factors affecting the efficacy of neoadjuvant therapy for esophageal cancer. This study will provide valuable information for further prospective clinical trials of neoadjuvant anti-PD-1 and other immunotherapy in esophageal cancer patients.
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
- •Histologically or cytologically confirmed resectable squamous-cell esophageal cancer ( cT1-2N+/ cT3-4aN0-3M0)
- •Eastern Cooperative Oncology Group (ECOG) status 0-1
- •Signed written informed consent prior to the implementation of any trial-related rocedures
- •Adequate organ function, evidenced by laboratory results with no contraindications to chemotherapy Absolute neutrophil count ≥ 1,500 х109/l Thrombocytes ≥ 100 х 109/l Hemoglobin ≥ 90 mg/l Creatinine ≤ 1.5 x ULN or creatinine clearance (calculated using the Cockcroft-Gault formula) ≥40 mL/min Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5 x upper limit of normal (ULN) Alkaline phosphatase (ALP) > 5 x ULN Bilirubin > 1.5 х ULN
排除标准
- •Patients diagnosed with any other malignant tumor
- •Patients at risk for tracheoesophageal fistula or aortoesophageal fistula
- •Have received prior therapy with: chemotherapy, radiation therapy,immune checkpoint inhibitor
- •Insufficient caloric and/or fluid intake despite consultation with a dietitian and/or tube feeding
- •Have an active infection requiring systemic therapy that has not resolved 3 days (simple infection, such as cystitis) to 7 days (severe infection, such as pyelonephritis) before the first dose of trial treatment
- •Patients who cannot tolerate chemoradiotherapy or surgery due to severe cardiac, lung dysfunction
- •A history of interstitial lung disease or non-infectious pneumonia
- •Active autoimmune disease with systemic therapy (ie, use of disease modifiers, corticosteroids, or immunosuppressive drugs) in the past 2 years
- •Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibody) and various viral hepatitis infections
- •Patients who have received allogeneic stem cell or solid organ transplantation
- •Women during pregnancy or lactation
研究组 & 干预措施
Tislelizumab arm
Radiotherapy: PTV 41.4Gy in 23 Fractions，5 days per week; Chemotherapy: Paclitaxel (Albumin bound) (100mg/m2) and Cisplatin (75 mg/m2) for 5 weeks, concurrent with radiotherapy; Immunotherapy: Tislelizumab (200mg per 3 weeks)
干预措施: Tislelizumab Combined With Neoadjuvant Radiotherapy and Chemotherapy (Drug)
结局指标
主要结局
Major Pathological Response Rate
时间窗: From date of surgery to 14 days later
No more than 10% of tumor cells were found in neoadjuvant surgical specimens.
Pathologic complete response rate
时间窗: From date of surgery to 14 days later
Pathologic complete response rate
次要结局
- Disease free survival(24 months)
- Incidence of Treatment-related Adverse Events(8 weeks)
研究者
Xue Meng
Ph.D, M.D
Shandong Cancer Hospital and Institute