[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100383869":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":36,"centralContacts":41,"locations":46,"responsibleParty":113,"collaborators":22,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":22,"eligibilityCriteria":122,"healthyVolunteers":118,"sex":123,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":22,"studyType":129,"phases":130,"briefSummary":133,"conditions":134,"keywords":22,"overallStatus":49,"whyStopped":22,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},{"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",[47,65,79,92,102],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Department 4th of Radiation Oncology, Anyang Cancer Hospital","RECRUITING","Anyang","Henan","455001","China","CN",{"type":56,"coordinates":57},"Point",[58,59],114.38278,36.096,{"lat":59,"lon":58},[62],{"name":63,"role":43,"phone":22,"phoneExt":22,"email":64},"Xiaomin Wang, MD","shine828@163.com",{"facility":66,"status":49,"city":67,"state":68,"zip":69,"country":53,"countryCode":54,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University","Changsha","Hunan","410031",{"type":56,"coordinates":71},[72,73],112.97087,28.19874,{"lat":73,"lon":72},[76],{"name":77,"role":43,"phone":22,"phoneExt":22,"email":78},"Qin Xiao, MD","xiaoqin_200909@163.com",{"facility":80,"status":49,"city":81,"state":82,"zip":83,"country":53,"countryCode":54,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Department of Radiation oncology, Jiangsu Cancer Hospital\u002FJiangsu Institute of Cancer Research\u002FThe affiliated Cancer Hospital of Nanjing Medical University","Nanjing","Jiangsu","210009",{"type":56,"coordinates":85},[86,87],118.77778,32.06167,{"lat":87,"lon":86},[90],{"name":91,"role":43,"phone":22,"phoneExt":22,"email":22},"Cheng Chen, MD",{"facility":93,"status":49,"city":81,"state":82,"zip":94,"country":53,"countryCode":54,"cosmosGeoPoint":95,"geoPoint":97,"contacts":98},"Department of Radiation oncology, Jiangsu Province Hospital\u002FThe First Affiliated Hospital with Nanjing Medical University","210029",{"type":56,"coordinates":96},[86,87],{"lat":87,"lon":86},[99],{"name":100,"role":43,"phone":22,"phoneExt":22,"email":101},"Xiaolin Ge, MD","doctorgxl@163.com",{"facility":103,"status":49,"city":104,"state":22,"zip":105,"country":53,"countryCode":54,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"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":56,"coordinates":107},[108,109],116.39723,39.9075,{"lat":109,"lon":108},[112],{"name":38,"role":43,"phone":44,"phoneExt":22,"email":45},{"type":40,"investigatorFullName":114,"investigatorTitle":115,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"XIN WANG","Principal Investigator","100383869","phase-1-chemoradiotherapy-in-unresectable-esophageal-cancer-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":127,"type":128},105,"ESTIMATED","INTERVENTIONAL",[131,132],"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.",[135,136,137,138],"Esophageal Cancer","Chemoradiotherapy","Albumin-bound Paxlitaxel","Unresectable Malignant Neoplasm","2024-12-10",{"date":141,"type":142},"2024-12-13","ACTUAL",{"date":144,"type":142},"2019-10-01",{"date":146,"type":128},"2026-12",{"name":5,"class":6},5]