[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100383869":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":36,"centralContacts":41,"locations":46,"responsibleParty":112,"collaborators":22,"id":115,"slug":22,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":22,"eligibilityCriteria":120,"healthyVolunteers":116,"sex":121,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":22,"studyType":127,"phases":128,"briefSummary":131,"conditions":132,"keywords":22,"overallStatus":49,"whyStopped":22,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Albumin-Bound Paclitaxel and Cisplatin based chemoradiotherapy","EXPERIMENTAL","Chemoradiotherapy arm receives intensity-modulated radiation therapy, volume modulated arc therapy or tomotherapy concurrently with albumin-bound paclitaxel and cisplatin (weekly intravenous infusion in 5-6 weeks).",[13,14,15],"Radiation: Radiotherapy","Drug: Albumin-Bound Paclitaxel","Drug: Cisplatin",[17,23,30],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"RADIATION","Radiotherapy","59.92Gy and 2.14Gy in 28 fractions to PGTV and 50.4Gy and 1.8Gy in 28 fractions 5 days every week in 5.5 weeks.",[9],null,{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Albumin-Bound Paclitaxel","100mg\u002Fd weekly,repeatedly on the first day,by intravenous infusion in 5-6 weeks.",[9],[29],"Nab-Paclitaxel",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Cisplatin","25mg\u002Fm2 weekly,by intravenous infusion in 5-6 weeks.",[9],[35],"platinum",[37],{"name":38,"affiliation":39,"role":40},"Xin Wang, MD","Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College","PRINCIPAL_INVESTIGATOR",[42],{"name":38,"role":43,"phone":44,"phoneExt":22,"email":45},"CONTACT","+861013311583220","beryl_wx2000@163.com",[47,64,78,91,101],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Department 4th of Radiation Oncology, Anyang Cancer Hospital","RECRUITING","Anyang","Henan","455001","China",{"type":55,"coordinates":56},"Point",[57,58],114.38278,36.096,{"lat":58,"lon":57},[61],{"name":62,"role":43,"phone":22,"phoneExt":22,"email":63},"Xiaomin Wang, MD","shine828@163.com",{"facility":65,"status":49,"city":66,"state":67,"zip":68,"country":53,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University","Changsha","Hunan","410031",{"type":55,"coordinates":70},[71,72],112.97087,28.19874,{"lat":72,"lon":71},[75],{"name":76,"role":43,"phone":22,"phoneExt":22,"email":77},"Qin Xiao, MD","xiaoqin_200909@163.com",{"facility":79,"status":49,"city":80,"state":81,"zip":82,"country":53,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Department of Radiation oncology, Jiangsu Cancer Hospital\u002FJiangsu Institute of Cancer Research\u002FThe affiliated Cancer Hospital of Nanjing Medical University","Nanjing","Jiangsu","210009",{"type":55,"coordinates":84},[85,86],118.77778,32.06167,{"lat":86,"lon":85},[89],{"name":90,"role":43,"phone":22,"phoneExt":22,"email":22},"Cheng Chen, MD",{"facility":92,"status":49,"city":80,"state":81,"zip":93,"country":53,"cosmosGeoPoint":94,"geoPoint":96,"contacts":97},"Department of Radiation oncology, Jiangsu Province Hospital\u002FThe First Affiliated Hospital with Nanjing Medical University","210029",{"type":55,"coordinates":95},[85,86],{"lat":86,"lon":85},[98],{"name":99,"role":43,"phone":22,"phoneExt":22,"email":100},"Xiaolin Ge, MD","doctorgxl@163.com",{"facility":102,"status":49,"city":103,"state":22,"zip":104,"country":53,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Department of Radiation Oncology, National Cancer Center\u002FNational Clinical Research Center for Cancer\u002FCancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)","Beijing","100021",{"type":55,"coordinates":106},[107,108],116.39723,39.9075,{"lat":108,"lon":107},[111],{"name":38,"role":43,"phone":44,"phoneExt":22,"email":45},{"type":40,"investigatorFullName":113,"investigatorTitle":114,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"XIN WANG","Principal Investigator","100383869",false,"NCT04278287","Chemoradiotherapy in Unresectable Esophageal Cancer","A Phase I\u002FII Study of Chemoradiotherapy Using Albumin-Bound Paclitaxel and Cisplatin in Unresectable Esophageal Squamous Cell Carcinomas Based on Nutritional Risk Screening Score (NRS2002)","Inclusion Criteria:\n\n* 18\\~75 years\n* Pathologically or cytologically proven unresectable esophageal squamous cell carcinomas in patients staged as T3N1M0-1b and T4N0-1M0-1b(AJCC 6th TNM staging,M1b limited to clavicular or celiac lymph node metastasis)\n* Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences\n* ECOG PS score: 0\\~1\n* NRS2002 score \\\u003C3\n* Estimated survival time ≥3 months\n* Normal organ and marrow function as defined below:\n\nHemoglobin: greater than or equal to 100g\u002FL ;Leukocytes: greater than or equal to 4,000 G\u002FL; Neutrophil: greater than or equal to 2,000 G\u002FL; Platelets: greater than or equal to 100,000\u002Fmm3 ; Creatinine: less than or equal to 1.5 times the upper limit or CCR greater than or equal to 60 ml\u002Fmin; AST\u002FALT: less than or equal to 2.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; INR: less than or equal to 1.5 times the upper limit; APTT: less than or equal to 1.5 times the upper limit; PT: less than or equal to 1.5 times the upper limit\n\n* Informed consent\n\nExclusion Criteria:\n\n* With any distant metastasis out of regional lymphatic drainage or in liver, lung, bone, CNS, etc\n* Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer\n* Existing active infection such as active tuberculosis and hepatitis\n* History of myocardial infarction within the past 6 months or history of ventricular arrhythmia\n* Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\n* History of allergic reactions attributed to paclitaxel, albumin or cisplatin\n* Participation in other clinical trials currently or within 4 weeks of selection\n* Pregnant or lactating females","ALL","18 Years","75 Years",{"count":125,"type":126},105,"ESTIMATED","INTERVENTIONAL",[129,130],"PHASE1","PHASE2","This phase I\u002FII clinical study is designed to evaluate the 1 year local tumor control rate of chemoradiotherapy using albumin-bound paclitaxel and cisplatin in unresectable esophageal squamous cell carcinomas based on Nutritional Risk Screening NRS2002.",[133,134,135,136],"Esophageal Cancer","Chemoradiotherapy","Albumin-bound Paxlitaxel","Unresectable Malignant Neoplasm","2024-12-10",{"date":139,"type":140},"2024-12-13","ACTUAL",{"date":142,"type":140},"2019-10-01",{"date":144,"type":126},"2026-12",{"name":5,"class":6},5]