[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648238":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":27,"locations":37,"responsibleParty":53,"collaborators":21,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":21,"enrollmentInfo":65,"targetDuration":21,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":79,"whyStopped":21,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Tianjin Medical University Cancer Institute and Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Response-guided Sequential Treatment","EXPERIMENTAL","Participants will receive neoadjuvant chemoimmunotherapy followed by individualized treatment according to early tumor response assessment. Patients with favorable response will proceed to surgery, while patients with insufficient response but remaining resectable disease will receive sequential chemoradiotherapy followed by surgery.",[13,14],"Drug: Neoadjuvant Chemoimmunotherapy (Tislelizumab Plus Paclitaxel and Cisplatin)","Radiation: Sequential Chemoradiotherapy",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Neoadjuvant Chemoimmunotherapy (Tislelizumab Plus Paclitaxel and Cisplatin)","Participants will receive neoadjuvant chemoimmunotherapy before surgery.\n\nThe regimen includes:\n\nTislelizumab (PD-1 inhibitor): 200 mg administered intravenously once every 3 weeks for 2 cycles.\n\nPaclitaxel: 135 mg\u002Fm² administered intravenously on Day 1 of each 3-week cycle for 2 cycles.\n\nCisplatin: 60 mg\u002Fm² administered intravenously on Day 1 of each 3-week cycle for 2 cycles.\n\nAfter completion of neoadjuvant chemoimmunotherapy, tumor response will be assessed. Treatment decisions will be guided by early response evaluation and multidisciplinary surgical assessment.",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"RADIATION","Sequential Chemoradiotherapy","Participants with inadequate response after neoadjuvant chemoimmunotherapy but remaining eligible for curative surgery will receive sequential chemoradiotherapy followed by surgery.\n\nConcurrent chemoradiotherapy consists of:\n\nRadiotherapy: 1.8 Gy per fraction, 5 fractions per week, for 5 weeks, with a total dose of 41.4 Gy in 23 fractions.\n\nChemotherapy: weekly concurrent chemotherapy with paclitaxel and platinum-based chemotherapy during radiotherapy.\n\nThe treatment aims to improve local tumor control before radical surgical resection.",[9],[28,33],{"name":29,"role":30,"phone":31,"phoneExt":21,"email":32},"Hongjing Jiang, PhD,MD","CONTACT","18622221069","jianghongjing@tmu.edu.cn",{"name":34,"role":30,"phone":35,"phoneExt":21,"email":36},"Chunyu Hou, PhD","13652037579","houchunyu@tjmuch.com",[38],{"facility":39,"status":21,"city":40,"state":21,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Department of minimally invasive esophageal surgery, Tianjin Medical University Cancer Institute and Hospital","Tianjin","300060","China","CN",{"type":45,"coordinates":46},"Point",[47,48],117.17667,39.14222,{"lat":48,"lon":47},[51],{"name":52,"role":30,"phone":31,"phoneExt":21,"email":32},"Hongjing Jiang",{"type":54,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100648238","phase-2-early-response-guided-sequential-radiotherapy-after-chemoimmunotherapy-for-locally-advanced-esophageal-squamous-cell-carcinoma-100648238",false,"NCT07721103","Early Response-guided Sequential Radiotherapy After Chemoimmunotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma","Early Response-guided Sequential Radiotherapy After Chemoimmunotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma: A Phase II Clinical Study","Keystone006","Inclusion Criteria:\n\n\\-\n\nParticipants must meet all of the following criteria:\n\nProvide written informed consent before enrollment.\n\nAge \\>18 years, male or female.\n\nHistologically confirmed thoracic esophageal squamous cell carcinoma (ESCC).\n\nLocally advanced, resectable disease according to AJCC\u002FUICC 8th edition TNM staging system, defined as:\n\ncT3-4aN0-2M0 or cT1-2N1-2M0;\n\nNo evidence of distant metastasis;\n\nConsidered initially resectable by a multidisciplinary surgical team.\n\nPatients who have received neoadjuvant chemoimmunotherapy and have measurable disease response assessment according to RECIST v1.1, including complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).\n\nAt least one measurable lesion according to RECIST version 1.1.\n\nEastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n\nExpected survival time \\>6 months.\n\nAdequate organ function meeting the following criteria:\n\nBone marrow function:\n\nAbsolute neutrophil count ≥1,500\u002Fmm³;\n\nPlatelet count ≥100,000\u002Fmm³;\n\nHemoglobin ≥9 g\u002FdL.\n\nRenal function:\n\nSerum creatinine ≤1.5 mg\u002FdL and\u002For creatinine clearance ≥60 mL\u002Fmin.\n\nHepatic function:\n\nTotal bilirubin ≤1.5 × upper limit of normal (ULN);\n\nAST and ALT ≤1.5 × ULN.\n\nParticipants of childbearing potential must agree to use medically approved contraception during study treatment and for 3 months after completion of treatment. Female participants of childbearing potential must have a negative serum or urine pregnancy test within 7 days before enrollment and must not be breastfeeding.\n\nWillingness and ability to comply with study procedures, safety assessments, and survival follow-up.\n\nExclusion Criteria:\n\n\\-\n\nParticipants will be excluded if any of the following criteria apply:\n\nEvidence of distant metastasis.\n\nPrevious or concurrent malignancy, except adequately treated basal cell carcinoma of skin or cervical carcinoma in situ.\n\nPrevious thoracic radiotherapy.\n\nPrevious treatment with PD-1, PD-L1, or CTLA-4 inhibitors, or known hypersensitivity to PD-1 inhibitors or macromolecular protein products.\n\nActive autoimmune disease or history of clinically significant autoimmune disease requiring systemic treatment.\n\nCurrent use of immunosuppressive therapy or systemic corticosteroids exceeding the equivalent of prednisone 10 mg\u002Fday within 2 weeks before enrollment.\n\nClinically significant ascites or pleural effusion requiring therapeutic drainage.\n\nUncontrolled cardiovascular disease, including:\n\nNYHA class II or higher heart failure;\n\nUnstable angina;\n\nMyocardial infarction within 1 year;\n\nClinically significant arrhythmias requiring treatment.\n\nSignificant coagulation abnormalities, bleeding tendency, or ongoing thrombolytic\u002Fanticoagulant therapy.\n\nActive gastrointestinal disorders associated with bleeding or perforation risk, including esophageal varices, active gastric\u002Fduodenal ulcer, ulcerative colitis, portal hypertension, or active tumor bleeding.\n\nHistory of severe bleeding, clinically significant hemoptysis, or thromboembolic events within specified periods.\n\nActive infection or unexplained fever \\>38.5°C before treatment initiation.\n\nAbdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks before study treatment.\n\nHistory or evidence of interstitial lung disease, pulmonary fibrosis, radiation pneumonitis, drug-induced pneumonitis, pneumoconiosis, or severe pulmonary impairment.\n\nKnown immunodeficiency, including HIV infection, or active hepatitis infection requiring exclusion according to protocol criteria.\n\nParticipation in another clinical trial within 1 month before enrollment or concurrent systemic anticancer therapy.\n\nReceipt of live vaccines within 4 weeks before treatment or planned live vaccination during study treatment.\n\nKnown history of substance abuse, alcoholism, or drug abuse.\n\nInability or unwillingness to comply with study-related procedures, examinations, or required costs.\n\nAny other medical, psychological, social, or safety-related condition judged by the investigator to make the participant unsuitable for study participation.","ALL","18 Years",{"count":66,"type":67},110,"ESTIMATED","INTERVENTIONAL",[70],"PHASE2","Esophageal squamous cell carcinoma (ESCC) is a common and aggressive malignancy with poor prognosis, particularly in patients with locally advanced disease. Neoadjuvant chemoimmunotherapy has shown promising antitumor activity and may improve pathological response; however, a proportion of patients achieve only stable disease (SD) or progressive disease (PD) after initial treatment and may have limited benefit from proceeding directly to surgery.\n\nThis prospective, single-center, phase II clinical study aims to evaluate an early response-guided sequential selective radiotherapy strategy after neoadjuvant chemoimmunotherapy in patients with locally advanced, resectable ESCC. Patients will initially receive neoadjuvant chemotherapy combined with PD-1 inhibitor therapy. Based on radiological response assessment, patients with major response (complete response or partial response) will proceed directly to radical surgery, whereas patients with insufficient response (stable disease or progressive disease but still considered resectable) will receive sequential chemoradiotherapy followed by surgery.\n\nThe study aims to assess the safety and efficacy of this individualized treatment strategy, with primary evaluation focusing on pathological response, surgical outcomes, and treatment-related adverse events. Exploratory analyses will investigate potential biomarkers associated with treatment response and prognosis.",[73],"Esophageal Squamous Cell Carcinoma (ESCC)",[75,76,77,78],"Locally advanced esophageal cancer","Neoadjuvant therapy","Adaptive treatment strategy","Response-guided therapy","NOT_YET_RECRUITING","2026-07-19",{"date":82,"type":83},"2026-07-22","ACTUAL",{"date":85,"type":67},"2026-07-14",{"date":87,"type":67},"2031-12-31",{"name":5,"class":6},1]