Teripalimab Plus Chemotherapy in Local Advanced Esophageal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Neoadjuvant Teripalimab Plus Chemotherapy in Local Advanced Esophageal Squamous Cancer

Conditions
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Squamous Cell Carcinoma, Esophageal Cancer, Perioperative Period

Intervention / Treatment
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* Drug: teripalimab plus chemotherapy
* Drug: chemotherapy plus teripalimab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: patients with local advanced esophageal squamous cell carcinoma receive two cycle of neoadjuvant chemotherapy and PD-1 antibody in the same day or chemotherapy followed by PD-1 antibody, and then surgery
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>teripalimab 240mg d1 paclitaxel 150-175mg/m2 d1 cisplatin 70-75mg/m2 d1 | Drug: teripalimab plus chemotherapy<br>* teripalimab 240mg d1 paclitaxel 150mg/m2 d1 cisplatin 70mg/m2 d1<br>* Other names: teripalimab and chemotherapy given on the same day;|
| Active Comparator: chemotherapy followed by immunotherapy<br>paclitaxel 150-175mg/m2 d1 cisplatin 70-75mg/m2 d1 teripalimab 240mg d3 | Drug: chemotherapy plus teripalimab<br>* paclitaxel 150mg/m2 d1 cisplatin 70mg/m2 d1 teripalimab 240mg d3<br>* Other names: chemotherapy followed by teripalimab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological complete response rate | the proportion of patients got pathological complete response rate | two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence rate of adverse events | the occurrence of adverse events | three month | 
| disease-free survival rate | the proportion of patients without relapse | three years |