[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621199":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":452,"collaborators":19,"id":454,"slug":455,"hasResults":456,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":19,"eligibilityCriteria":460,"healthyVolunteers":456,"sex":461,"minAge":462,"maxAge":463,"enrollmentInfo":464,"targetDuration":19,"studyType":467,"phases":468,"briefSummary":471,"conditions":472,"keywords":19,"overallStatus":209,"whyStopped":19,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":483},{"fullName":5,"class":6},"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TQB6411 Injection","EXPERIMENTAL","TQB6411 Injection, 21 days as a treatment cycle.\n\nTQB6411 injection, 28 days as a treatment cycle.",[13],"Drug: TQB6411 Injection",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","TQB6411 Injection is an antibody-drug conjugate (ADC) targeting Epidermal Growth Factor Receptor (EGFR)\u002Fc-Met.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Feng Wang, Doctor","CONTACT","13938244776","fengw010@163.com",[27,46,61,76,91,106,121,135,149,164,179,193,207,219,229,244,259,270,284,299,310,320,335,350,364,379,390,408,423,441],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"The Second Affiliated Hospital of Anhui Medical University","NOT_YET_RECRUITING","Hefei","Anhui","230061","China","CN",{"type":36,"coordinates":37},"Point",[38,39],117.28083,31.86389,{"lat":39,"lon":38},[42],{"name":43,"role":23,"phone":44,"phoneExt":19,"email":45},"Mingjun Zhang, Master","13865952007","mjzhang2010@outlook.com",{"facility":47,"status":29,"city":48,"state":49,"zip":50,"country":33,"countryCode":34,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"Cancer Hospital Chinese Academy of Medical Sciences","Beijing","Beijing Municipality","100021",{"type":36,"coordinates":52},[53,54],116.39723,39.9075,{"lat":54,"lon":53},[57],{"name":58,"role":23,"phone":59,"phoneExt":19,"email":60},"Jing Huang, Doctor","13301056087","huangjingwg@163.com",{"facility":62,"status":29,"city":63,"state":64,"zip":65,"country":33,"countryCode":34,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Fujian Cancer Hospital","Fuzhou","Fujian","350000",{"type":36,"coordinates":67},[68,69],119.30611,26.06139,{"lat":69,"lon":68},[72],{"name":73,"role":23,"phone":74,"phoneExt":19,"email":75},"Zhangzhou Huang, Bachelor","13609578088","1609305255@qq.com",{"facility":77,"status":29,"city":78,"state":79,"zip":80,"country":33,"countryCode":34,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Gansu Provincial Tumor Hospital","Lanzhou","Gansu","730050",{"type":36,"coordinates":82},[83,84],103.83987,36.05701,{"lat":84,"lon":83},[87],{"name":88,"role":23,"phone":89,"phoneExt":19,"email":90},"Zhihu Li, Master","18993042850","245698692@qq.com",{"facility":92,"status":29,"city":93,"state":94,"zip":95,"country":33,"countryCode":34,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"The First Affiliated Hospital of Shantou University Medical College","Shantou","Guangdong","515000",{"type":36,"coordinates":97},[98,99],116.67876,23.35489,{"lat":99,"lon":98},[102],{"name":103,"role":23,"phone":104,"phoneExt":19,"email":105},"Liming Chen, Doctor","13923909199","angelchen08@sina.com",{"facility":107,"status":29,"city":108,"state":109,"zip":110,"country":33,"countryCode":34,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Guangxi Medical University Cancer Hospital","Nanning","Guangxi","530021",{"type":36,"coordinates":112},[113,114],108.31667,22.81667,{"lat":114,"lon":113},[117],{"name":118,"role":23,"phone":119,"phoneExt":19,"email":120},"Jiangqiong Huang, Doctor","13978809340","947095887@qq.com",{"facility":122,"status":29,"city":109,"state":123,"zip":124,"country":33,"countryCode":34,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Guizhou Provincial People's Hospital","Guizhou","550002",{"type":36,"coordinates":126},[127,128],109.352,26.8497,{"lat":128,"lon":127},[131],{"name":132,"role":23,"phone":133,"phoneExt":19,"email":134},"Yu Zhang, Doctor","18885146684","248634489@qq.com",{"facility":136,"status":29,"city":137,"state":123,"zip":138,"country":33,"countryCode":34,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"The Second Affiliated Hospital of Zunyi Medical University","Zunyi","563006",{"type":36,"coordinates":140},[141,142],106.90722,27.68667,{"lat":142,"lon":141},[145],{"name":146,"role":23,"phone":147,"phoneExt":19,"email":148},"Zhou Jianguo, Doctor","18785237902","jianguo905@163.com",{"facility":150,"status":29,"city":151,"state":152,"zip":153,"country":33,"countryCode":34,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Harbin Medical University Cancer Hospital","Harbin","Heilongjiang","150000",{"type":36,"coordinates":155},[156,157],126.65,45.75,{"lat":157,"lon":156},[160],{"name":161,"role":23,"phone":162,"phoneExt":19,"email":163},"Zhiwei Li, Doctor","15004683651","lzhw0451@163.com",{"facility":165,"status":29,"city":166,"state":167,"zip":168,"country":33,"countryCode":34,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"Anyang Cancer Hospital","Anyang","Henan","455000",{"type":36,"coordinates":170},[171,172],114.38278,36.096,{"lat":172,"lon":171},[175],{"name":176,"role":23,"phone":177,"phoneExt":19,"email":178},"Jin Xia, Master","15890750990","15890750990@126.com",{"facility":180,"status":29,"city":181,"state":167,"zip":182,"country":33,"countryCode":34,"cosmosGeoPoint":183,"geoPoint":187,"contacts":188},"The Second People's Hosital of Jiaozuo","Jiaozuo","454001",{"type":36,"coordinates":184},[185,186],113.23914,35.23925,{"lat":186,"lon":185},[189],{"name":190,"role":23,"phone":191,"phoneExt":19,"email":192},"Li Li, Doctor","18603912883","liliwqf@163.com",{"facility":194,"status":29,"city":195,"state":167,"zip":196,"country":33,"countryCode":34,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"Luoyang Central Hospital (Zhengzhou University Affiliated Luoyang Central Hospital)","Luoyang","471000",{"type":36,"coordinates":198},[199,200],112.43684,34.67345,{"lat":200,"lon":199},[203],{"name":204,"role":23,"phone":205,"phoneExt":19,"email":206},"Tiejun Ren, Master","13937967667","lysrtj@126.com",{"facility":208,"status":209,"city":210,"state":167,"zip":211,"country":33,"countryCode":34,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"The first affiliated hospital of Zhengzhou university","RECRUITING","Zhengzhou","450000",{"type":36,"coordinates":213},[214,215],113.64861,34.75778,{"lat":215,"lon":214},[218],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},{"facility":220,"status":29,"city":210,"state":167,"zip":211,"country":33,"countryCode":34,"cosmosGeoPoint":221,"geoPoint":223,"contacts":224},"Zhengzhou Central Hospital",{"type":36,"coordinates":222},[214,215],{"lat":215,"lon":214},[225],{"name":226,"role":23,"phone":227,"phoneExt":19,"email":228},"Fang Liang, Master","13938203863","fangfang0800@sina.com",{"facility":230,"status":29,"city":231,"state":232,"zip":233,"country":33,"countryCode":34,"cosmosGeoPoint":234,"geoPoint":238,"contacts":239},"Hunan Provincial People's Hospital","Changsha","Hunan","410005",{"type":36,"coordinates":235},[236,237],112.97087,28.19874,{"lat":237,"lon":236},[240],{"name":241,"role":23,"phone":242,"phoneExt":19,"email":243},"Huaxin Duan, Doctor","13347315509","317102912@qq.com",{"facility":245,"status":29,"city":246,"state":247,"zip":248,"country":33,"countryCode":34,"cosmosGeoPoint":249,"geoPoint":253,"contacts":254},"Jiangsu Cancer Hospital","Nanjing","Jiangsu","210000",{"type":36,"coordinates":250},[251,252],118.77778,32.06167,{"lat":252,"lon":251},[255],{"name":256,"role":23,"phone":257,"phoneExt":19,"email":258},"Xiaohua Wang, Doctor","13676799069","wangxiaohua@jszlyy.com.cn",{"facility":260,"status":29,"city":246,"state":247,"zip":261,"country":33,"countryCode":34,"cosmosGeoPoint":262,"geoPoint":264,"contacts":265},"Jiangsu Provincial Hospital of Traditional Chinese Medicine","210019",{"type":36,"coordinates":263},[251,252],{"lat":252,"lon":251},[266],{"name":267,"role":23,"phone":268,"phoneExt":19,"email":269},"Jun Qian, Doctor","13951702380","1836141816@qq.com",{"facility":271,"status":29,"city":272,"state":247,"zip":273,"country":33,"countryCode":34,"cosmosGeoPoint":274,"geoPoint":278,"contacts":279},"Northern Jiangsu People's Hospital","Yangzhou","225009",{"type":36,"coordinates":275},[276,277],119.43583,32.39722,{"lat":277,"lon":276},[280],{"name":281,"role":23,"phone":282,"phoneExt":19,"email":283},"Xianwen Zhang, Doctor","18051060926","zhangxwok@163.com",{"facility":285,"status":29,"city":286,"state":287,"zip":288,"country":33,"countryCode":34,"cosmosGeoPoint":289,"geoPoint":293,"contacts":294},"The first hospital of jilin university","Changchun","Jilin","130012",{"type":36,"coordinates":290},[291,292],125.32278,43.88,{"lat":292,"lon":291},[295],{"name":296,"role":23,"phone":297,"phoneExt":19,"email":298},"Wei Li, Doctor","13756661267","jdyylw@163.com",{"facility":300,"status":29,"city":286,"state":287,"zip":301,"country":33,"countryCode":34,"cosmosGeoPoint":302,"geoPoint":304,"contacts":305},"Jilin Cancer Hospital","130021",{"type":36,"coordinates":303},[291,292],{"lat":292,"lon":291},[306],{"name":307,"role":23,"phone":308,"phoneExt":19,"email":309},"Haifeng Liu, Master","0431-80596336","HFLIU2025@163.com",{"facility":311,"status":29,"city":312,"state":313,"zip":314,"country":33,"countryCode":34,"cosmosGeoPoint":19,"geoPoint":19,"contacts":315},"Linyi cancer Hospital","Liyi","Shandong","276034",[316],{"name":317,"role":23,"phone":318,"phoneExt":19,"email":319},"Shuhong Liu, Master","13953959036","liushuhonglz.2008@163.com",{"facility":321,"status":29,"city":322,"state":323,"zip":324,"country":33,"countryCode":34,"cosmosGeoPoint":325,"geoPoint":329,"contacts":330},"Shanghai Chest Hospital","Shanghai","Shanghai Municipality","200030",{"type":36,"coordinates":326},[327,328],121.45806,31.22222,{"lat":328,"lon":327},[331],{"name":332,"role":23,"phone":333,"phoneExt":19,"email":334},"Xuwei Cai, Doctor","13817512612","birdhome2000@163.com",{"facility":336,"status":29,"city":337,"state":338,"zip":339,"country":33,"countryCode":34,"cosmosGeoPoint":340,"geoPoint":344,"contacts":345},"Shanxi Bethune Hospital","Taiyuan","Shanxi","030000",{"type":36,"coordinates":341},[342,343],112.56028,37.86944,{"lat":343,"lon":342},[346],{"name":347,"role":23,"phone":348,"phoneExt":19,"email":349},"Yarong Guo, Doctor","13453410624","gyr5258@126.com",{"facility":351,"status":29,"city":352,"state":338,"zip":353,"country":33,"countryCode":34,"cosmosGeoPoint":354,"geoPoint":358,"contacts":359},"The Second Affiliated Hospital of Air Force Medical University","Xi’an","710000",{"type":36,"coordinates":355},[356,357],113.52486,35.99785,{"lat":357,"lon":356},[360],{"name":361,"role":23,"phone":362,"phoneExt":19,"email":363},"Haichuan Su, Doctor","18629190366","cntdgcp@163.com",{"facility":365,"status":29,"city":366,"state":367,"zip":368,"country":33,"countryCode":34,"cosmosGeoPoint":369,"geoPoint":373,"contacts":374},"Sichuan cancer hosipital","Chengdu","Sichuan","610040",{"type":36,"coordinates":370},[371,372],104.06667,30.66667,{"lat":372,"lon":371},[375],{"name":376,"role":23,"phone":377,"phoneExt":19,"email":378},"Qifeng Wang, Doctor","18227667667","littlecancer@163.com",{"facility":380,"status":29,"city":366,"state":367,"zip":381,"country":33,"countryCode":34,"cosmosGeoPoint":382,"geoPoint":384,"contacts":385},"Sichuan Provincial People's Hospital","610072",{"type":36,"coordinates":383},[371,372],{"lat":372,"lon":371},[386],{"name":387,"role":23,"phone":388,"phoneExt":19,"email":389},"Xueqiang Zhu, Master","189 8183 8387","zhuxueqiang1234@163.com",{"facility":391,"status":29,"city":392,"state":367,"zip":393,"country":33,"countryCode":34,"cosmosGeoPoint":394,"geoPoint":398,"contacts":399},"Affiliated Hospital of Southwest Medical University","Luzhou","64600",{"type":36,"coordinates":395},[396,397],105.42575,28.8903,{"lat":397,"lon":396},[400,404],{"name":401,"role":23,"phone":402,"phoneExt":19,"email":403},"Peirong Ren, Master","15883037066","1097802221@qq.com",{"name":405,"role":23,"phone":406,"phoneExt":19,"email":407},"Qing Peng, Doctor","18181873310","qingpeng9712118@163.com",{"facility":409,"status":29,"city":410,"state":411,"zip":412,"country":33,"countryCode":34,"cosmosGeoPoint":413,"geoPoint":417,"contacts":418},"Tianjin Medical University Cancer Institute & Hospital","Tianjin","Tianjin Municipality","300000",{"type":36,"coordinates":414},[415,416],117.17667,39.14222,{"lat":416,"lon":415},[419],{"name":420,"role":23,"phone":421,"phoneExt":19,"email":422},"Ting Deng, Doctor","15802243063","xymcdengting@126.com",{"facility":424,"status":29,"city":425,"state":426,"zip":427,"country":33,"countryCode":34,"cosmosGeoPoint":428,"geoPoint":432,"contacts":433},"The First Affiliated Hospital of Wenzhou Medical University","Wenzhou","Zhejiang","325000",{"type":36,"coordinates":429},[430,431],120.66682,27.99942,{"lat":431,"lon":430},[434,437],{"name":435,"role":23,"phone":257,"phoneExt":19,"email":436},"Liping Tao, Master","drlipingtao@163.com",{"name":438,"role":23,"phone":439,"phoneExt":19,"email":440},"Xuebang Zhang, Master","13777760353","Baxuza@126.com",{"facility":442,"status":29,"city":322,"state":19,"zip":443,"country":33,"countryCode":34,"cosmosGeoPoint":444,"geoPoint":446,"contacts":447},"Zhongshan Hospital Fudan University","200032",{"type":36,"coordinates":445},[327,328],{"lat":328,"lon":327},[448],{"name":449,"role":23,"phone":450,"phoneExt":19,"email":451},"Tianshu Liu, Doctor","13681973996","liu.tianshu@zs-hospital.sh.cn",{"type":453,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100621199","phase-1-clinical-trial-evaluating-tqb6411-injection-in-participant-s-with-esophageal-cancer-100621199",false,"NCT07367516","Clinical Trial Evaluating TQB6411 Injection in Participant s With Esophageal Cancer","A Phase Ib\u002FII Clinical Trial Evaluating the Safety and Efficacy of TQB6411 Injection in Participant s With Recurrent or Metastatic Esophageal Cancer Who Have Failed Prior PD-1\u002FPD-L1 Inhibitor Plus Platinum-Based Chemotherapy","Inclusion Criteria:\n\n* Participants voluntarily participate in this study, sign the informed consent form, and demonstrate good compliance.\n* Age between 18 and 75 years old (inclusive)\n* Eastern Cooperative Oncology Group (ECOG) score of 0-1\n* Expected survival \\>12 weeks\n* At least one measurable lesion per RECIST v1.1\n* Laboratory criteria(no hematopoietic growth factor correction within 7 days)：\n\n  * Hemoglobin (HGB) ≥90 g\u002FL;\n  * Absolute neutrophil count (NEUT) ≥1.5×10⁹\u002FL;\n  * Platelets (PLT) ≥90×10⁹\u002FL;\n  * Total bilirubin (TBIL) ≤1.5×ULN;\n  * Alanine Aminotransferase (ALT)\u002FAspartate Aminotransferase (AST) ≤2.5×ULN (≤5×ULN if liver metastases present);\n  * Serum creatinine (CR) ≤1.3×ULNorcreatinine clearance rate (CCR) ≥50 mL\u002Fmin;\n* Histologically\u002Fcytologically confirmed recurrent or metastatic Esophageal cancer\n* Failure\u002Fintolerance to prior PD-1\u002FPD-L1 inhibitor plus platinum-based chemotherapy for recurrent\u002Fmetastatic Esophageal Carcinoma (EC)\n* Willingness to provide archived or fresh tumor tissue for biomarker analysis.\n* Females of childbearing potential: Negative serum\u002Furine pregnancy test within 7 days before enrollment and agreement to use effective contraception during and for 6 months post-study. Males: Agreement to use effective contraception during and for 6 months post-study.\n\nExclusion Criteria:\n\n* Current or History of Other Malignancies\n* Participants with any condition that may compromise venous access for drug administration or blood sampling are excluded.\n* Participants with prior treatment-related adverse reactions that have not recovered to ≤ Grade 1 per CTCAE v5.0 criteria.\n* Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose, Scheduled major surgery during the study intervention period, Non-healing wound, ulcer, or bone fracture at screening\n* Participants with any bleeding\u002Fhemorrhagic event ≥ Grade 3 (per CTCAE v5.0) occurring within 4 weeks before the first dose are excluded\n* History of Thromboembolic Events within 6 Months\n* Poorly Controlled Active Viral Hepatitis\n* Participants with active syphilis infection requiring antimicrobial therapy are excluded\n* Participants with any of the following pulmonary conditions are excluded: active tuberculosis, idiopathic pulmonary fibrosis (IPF), organizing pneumonia, drug-induced\u002Fradiation pneumonitis requiring treatment, symptomatic active pneumonia, or history of interstitial lung disease (ILD) requiring therapy\n* History of Substance Abuse or Psychiatric Disorders\n* History of Allogeneic Transplantation (Bone Marrow or Solid Organ)\n* History of Hepatic Encephalopathy\n* Major Cardiovascular Diseases\n* Active or Uncontrolled Severe Infections\n* Renal Failure Requiring Dialysis (Hemodialysis\u002FPeritoneal Dialysis)\n* History of Immunodeficiency\n* Poorly Controlled Autoimmune Disease\n* Poorly Controlled Autoimmune Disease \\& Epilepsy Requiring Treatment\n* Poorly Controlled Diabetes\n* Tumor-Related Symptoms and Treatment Considerations：\n\n  * Exclusion Criterion - Recent Anticancer Treatment (≤3 Weeks or Within 5 Half-Lives)\n  * Recent Use of National Medical Products Administration (NMPA) -Approved Anticancer Traditional Chinese Medicine (≤1 Week Prior to Treatment)\n  * Radiologically Confirmed Tumor Encasement of Major Vessels with High Bleeding Risk\n  * Uncontrolled Effusions Requiring Repeated Drainage\n  * Known to have spinal cord compression, leptomeningeal metastasis\u002Fcarcinomatous meningitis, or symptomatic brain metastases with less than 4 weeks of symptom\u002Fimaging control.\n* Known Hypersensitivity to Investigational Drug or Excipients\n* Prior Treatment with Topoisomerase I Inhibitor-Based ADCs and\u002For Irinotecan Chemotherapy\n* Prior Participation in Anticancer Clinical Trials Within 4 Weeks\n* Investigator-Assessed Safety or Compliance Concerns","ALL","18 Years","75 Years",{"count":465,"type":466},105,"ESTIMATED","INTERVENTIONAL",[469,470],"PHASE1","PHASE2","The Phase Ib stage of this study primarily aims to evaluate the tolerance and safety of TQB6411 Injection in participants with recurrent or metastatic Esophageal cancer who have previously failed treatment with PD-1\u002FPD-L1 monoclonal antibodies combined with platinum-based chemotherapy. The Phase II stage primarily aims to evaluate the efficacy of TQB6411 Injection in this same participants population.",[473],"Esophageal Cancer","2026-06-30",{"date":476,"type":477},"2026-07-02","ACTUAL",{"date":479,"type":477},"2026-02-12",{"date":481,"type":466},"2027-03",{"name":5,"class":6},30]