[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100384064":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":37,"responsibleParty":57,"collaborators":23,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":23,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":23,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":81,"overallStatus":40,"whyStopped":23,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Henan Cancer Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Neoadjuvant immunochemotherapy","EXPERIMENTAL","Neo-adjuvant chemotherapy(cisplatin and paclitaxel):\n\nPaclitaxel, 175mg\u002Fm2, d1, Cisplatin, 75mg\u002Fm2, d1, 3 week, 2 cycles. JS001, 240mg ivgtt, d3, \\>30min, 3week, 2 cycles\n\nSurgery:\n\n2-3weeks after Neo-adjuvant chemotherapy Surgeons: the operation shall be performed by senior thoracic surgeons. Try to achieve the consistency of operation quality.\n\nOperation: the thoracic esophagectomy must be through right thoracic cavity. (open and minimally invasive McKeown or Ivor Lewis). Total two-field lymphadenectomy (right and left recurrent laryngeal nerve lymph nodes must be included).\n\nAfter surgery\u002F maintain period:\n\nJS001, 240mg ivgtt, d3, \\>30min, 3week (8 cycles at most)",[13],"Drug: Neoadjuvant immunochemotherapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Neoadjuvant chemotherapy","ACTIVE_COMPARATOR","Neo-adjuvant chemotherapy(cisplatin and paclitaxel):\n\nPaclitaxel, 175mg\u002Fm2, d1, Cisplatin, 75mg\u002Fm2, d1, 3 week, 2 cycles.\n\nSurgery:\n\n2-3weeks after Neo-adjuvant chemotherapy Surgeons: the operation shall be performed by senior thoracic surgeons. Try to achieve the consistency of operation quality.\n\nOperation: the thoracic esophagectomy must be through right thoracic cavity. (open and minimally invasive McKeown or Ivor Lewis). Total two-field lymphadenectomy (right and left recurrent laryngeal nerve lymph nodes must be included).",[13],[20],{"type":21,"name":9,"description":11,"armGroupLabels":22,"otherNames":23},"DRUG",[15,9],null,[25],{"name":26,"affiliation":27,"role":28},"Yan Zheng, PhD, MD","Henan Cancer Hospital\u002FThe affiliated Cancer Hospital of ZhengZhou university","PRINCIPAL_INVESTIGATOR",[30,34],{"name":26,"role":31,"phone":32,"phoneExt":23,"email":33},"CONTACT","+86+15713660065","sunnyzheng1@126.com",{"name":35,"role":31,"phone":23,"phoneExt":23,"email":36},"Haibo Sun, PhD, MD","sunny-haipo@hotmail.com",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Henan Cancer Hospital (The Affiliated Cancer Hospital of Zhengzhou University)","RECRUITING","Zhengzhou","Henan","450003","China","CN",{"type":47,"coordinates":48},"Point",[49,50],113.64861,34.75778,{"lat":50,"lon":49},[53,56],{"name":54,"role":31,"phone":55,"phoneExt":23,"email":33},"Yan Zheng, PhD","86-371-65587226",{"name":54,"role":28,"phone":23,"phoneExt":23,"email":23},{"type":58,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100384064","phase-3-neo-adjuvant-immunochemotheray-versus-neo-adjuvant-chemotherapy-for-resectable-esophageal-carcinoma-100384064",false,"NCT04280822","Neo-adjuvant Immunochemotheray Versus Neo-adjuvant Chemotherapy for Resectable Esophageal Carcinoma","A Phase III, Randomized Controlled Study of Neo-adjuvant Toripalimab (JS001) in Combination With Chemotherapy Versus Neo-adjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Histologic diagnosis of local advance squamous cell thoracic esophageal carcinoma of Stage (T1N1-3 or T2-3N0-3 M0), (8th Union for International Cancer Control, UICC-TNM).\n2. No metastatic lymph node in cervical by color doppler sonography.\n3. Patients must not have received any prior anticancer therapy of esophageal carcinoma.\n4. Age ranges from 18 to 75 years.\n5. Without operative contraindication.\n6. Absolute white blood cells count ≥4.0×109\u002FL, neutrophil ≥1.5×109\u002FL, platelets ≥100.0×109\u002FL, hemoglobin ≥90g\u002FL, and normal functions of liver and kidney, total bilirubin（TBIL）≤1.5N, aspartate aminotransferase (AST)≤2.5N, alanine aminotransferase(ALT)≤2.5N, prothrombin time(PT)≤1.5N, and activated partial thromboplastin time(APTT) is in normal range, endogenous creatinine clearance rate(CRE)≤1.5N.\n7. Patients must not have diagnosed with other cancer and must not received any prior anticancer therapy except prostatic cancer with more than 5 years disease-free survival(DFS).\n8. expected R0 resection.\n9. ECOG 0～1.\n10. Patients should agree to use contraceptive measures during the study period and within 6 months of the end of the study. Women must be non-lactation.\n11. Signed informed consent document on file. 10. .\n\nExclusion Criteria:\n\n* 1\\. Multiple primary cancer. 2.Patients with infections disease that require treatment 3.Patients who need continuous hormone treatment 4.unstable angina within 3 months, myocardial infarction within 6 months 5.psychopath 6.Patients with concomitant hemorrhagic disease. 7.Any unexpected reason for patients can't get operation 8.Inability to use gastric conduit after esophagectomy because of a prior surgery.\n\n  9.Pregnant or breast feeding 10.Patients are diagnosed or suspected to be allergic to cisplatin or Paclitaxel.\n\n  11.Bronchial asthma who requires intermittent use of bronchodilators or medical interventions 12.Due to co-existing diseases, the immunosuppressant was used. And the dosage of immunosuppressant was more than 10mg\u002F day orally and more than 2 weeks before enrollment 13.Abnormal coagulation function (PT\\>16s, APTT\\>53s, TT\\>21s, Fib\\\u003C1.5g\u002FL), tendency of bleeding or receiving thrombolysis or anticoagulant therapy 14.Previous or present pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, lung function severely impaired 15.Autoimmune diseases, immune deficiency, organ transplantation； 16.Hepatitis b\u002Fc patients。","ALL","18 Years","75 Years",{"count":70,"type":71},400,"ESTIMATED","INTERVENTIONAL",[74],"PHASE3","The effect of neo-adjuvant immunochemotherapy on survival of patients with thoracic esophageal squamous cell carcinomas remains unknown. One of our objectives is to evaluate whether the neo-adjuvant immunochemotherapy Toripalimab (JS001) with cisplatin and paclitaxel followed by right thoracic approach esophagectomy with total 2-field lymph node dissection improves the overall survival of thoracic esophageal cancer patients versus neo-adjuvant chemotherapy.",[77,78,79,80],"Esophageal Cancer","Surgery","Neoadjuvant Treatment","Survival",[15,9],"2022-10-02",{"date":84,"type":85},"2022-10-04","ACTUAL",{"date":87,"type":85},"2020-04-21",{"date":89,"type":71},"2028-03-02",{"name":5,"class":6},1]