Neoadjuvant Teripalimab Plus Chemotherapy in Local Advanced Esophageal Squamous Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pathological complete response rate
研究概览
简要总结
The prognosis of locally advanced esophageal squamous cell carcinoma is poor,the role of chemotherapy as neoadjuvant therapy in locally advanced esophageal cancer has been established, which can convert some unresectable esophageal cancer into resectable esophageal cancer.PD-1 antibody has been shown to improve the pathological complete response rate in NSCLC, however, the data in neoadjuvant of esophageal squamous carcinoma is relatively rare. This study was designed to know the value of PD-1 antibody in neoadjuvant therapy of esophageal cancer.
详细描述
The prognosis of locally advanced esophageal squamous cell carcinoma is poor, the 5-year survival rate is less than 50%. It is necessary to conduct studies in these patients to reduce the rate of postoperative recurrence and prolong the disease-free survival. The role of chemotherapy as neoadjuvant therapy in locally advanced esophageal cancer has been established, which can convert some unresectable esophageal cancer into resectable esophageal cancer. The PD-1 antibody, teripalimab, is an immunological checkpoint inhibitor that has shown clinical efficacy in advanced esophageal cancer, but there has been relatively few data on neoadjuvant therapy. This study was designed to comprehend the pathological complete response rate, disease-free survival, and safety of neoadjuvant therapy with chemotherapy plus teriprilin patients with locally advanced esophageal squamous cell carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thoracic esophageal squamous cell carcinoma diagnosed by pathology
- •no distant metastasis, the diseases could be resected or potentially resectable assessed by thoracic oncologist
- •ECOG score 0-1
- •clinical stage is stage II, III, and IVa according to AJCC 8.0
- •expected lifespan > 3 months
- •enough organ function
- •normal blood pressure, for patients with hypertension, the blood pressure should be controlled in normal level by antihypertension
- •the fasting blood sugar should be ≤ 8mmol / L for diabetic patients
- •no other serious diseases (such as autoimmune diseases, immunodeficiencies, organ transplants) that conflict with this study
- •no history of other malignant tumors
- •women of childbearing period must be tested negative for blood pregnancy within 7 days, and subjects of childbearing age must use appropriate contraceptive measures during the trial period and within 6 months after the trial;
- •The patient agrees to participate in the clinical study and sign the Informed Consent Form.
排除标准
- •suffering from serious infectious diseases within 4 weeks before enrollment;
- •patients with bronchial asthma requires intermittent use of bronchodilators or medical interventions;
- •usage of immunosuppressants before the enrollment, the amount of immunosuppressant used ≥10mg / day oral prednisone for more than 2 weeks
- •clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction, unstable or severe angina, coronary artery bypass surgery, congestive heart failure, and room requiring medical intervention within the first 6 months of enrollment arrhythmia, left ventricular ejection fraction <50%
- •severe allergies
- •severe mental disorder
- •abnormal blood coagulation function (PT>16s, APTT>53s, TT>21s, Fib<1.5g/L), bleeding tendency or receiving thrombolysis or anticoagulant therapy
- •previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, severe lung damage, etc
- •other situations evaluated by investigators not meet the enrollment
研究组 & 干预措施
treatment group
teripalimab 240mg d1 paclitaxel 150-175mg/m2 d1 cisplatin 70-75mg/m2 d1
干预措施: teripalimab plus chemotherapy (Drug)
chemotherapy followed by immunotherapy
paclitaxel 150-175mg/m2 d1 cisplatin 70-75mg/m2 d1 teripalimab 240mg d3
干预措施: chemotherapy plus teripalimab (Drug)
结局指标
主要结局
Pathological complete response rate
时间窗: two months
the proportion of patients got pathological complete response rate
次要结局
- occurrence rate of adverse events(three month)
- disease-free survival rate(three years)