[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607403":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":33,"studyPopulation":33,"armGroups":40,"interventions":47,"overallOfficials":33,"centralContacts":51,"locations":57,"responsibleParty":72,"collaborators":33,"id":74,"slug":33,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":33,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":33,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":60,"whyStopped":33,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Anhui Provincial Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":33},[9,13],{"measure":10,"description":11,"timeFrame":12},"PFS","progression free survival","From date of enrollment until the date of first documented progression (radiologic or clinical), assessed every 8 weeks up to 36 months",{"measure":14,"description":14,"timeFrame":15},"Advese Events","Assessed every 8 weeks up to 36 months from the date of enrollment",[17,21,25,29],{"measure":18,"description":19,"timeFrame":20},"OS","overall survival","From date of enrollment until the date of death from any cause, assessed up to 36 months",{"measure":22,"description":23,"timeFrame":24},"ORR","Objective Response Rate","From enrollment to the time of the second radiological evaluation",{"measure":26,"description":27,"timeFrame":28},"DOR","Duration of Response","the period from the first assessment of Complete Response (CR) or Partial Response (PR) to the first occurrence of Progressive Disease (PD) or death.",{"measure":30,"description":31,"timeFrame":32},"DCR","Disease Control Rate","From enrollment to the time of second radiological evaluation",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":33,"primaryPurpose":37,"observationalModel":33,"timePerspective":33,"maskingInfo":38},"NA","SINGLE_GROUP","TREATMENT",{"masking":39,"maskingDescription":33,"whoMasked":33},"NONE",[41],{"label":42,"type":43,"description":44,"interventionNames":45},"Ivonescimab+Radiotherapy","EXPERIMENTAL","Short-course hypofractionated radiotherapy was administered to progressive lesions after first-line treatment, with a prescribed dose of 20 Gy in 5 fractions (95% PTV). The monoclonal antibody was initiated within 1 week after completing the radiotherapy regimen, at a dose of 20 mg\u002Fkg. Ivonescimab was administered every three weeks until disease progression, intolerable toxicity, or patient refusal.",[46],"Drug: Ivonescimab+Radiotherapy",[48],{"type":49,"name":42,"description":44,"armGroupLabels":50,"otherNames":33},"DRUG",[42],[52],{"name":53,"role":54,"phone":55,"phoneExt":33,"email":56},"Huiquan Liu","CONTACT","+86 15005518171","759821691@qq.com",[58],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":33},"Anhui Provincal Hospital","RECRUITING","Hefei","Anhui","230000","China","CN",{"type":67,"coordinates":68},"Point",[69,70],117.28083,31.86389,{"lat":70,"lon":69},{"type":73,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100607403",false,"NCT07188103","Ivonescimab Plus Short-Course Hypofractionated Radiotherapy as Second-Line Therapy for Esophageal Squamous Cell Carcinoma","Efficacy and Safety of Ivonescimab Combined With Short-Course Hypofractionated Radiotherapy as Second-Line Therapy for Locally Advanced\u002FMetastatic Esophageal Squamous Cell Carcinoma: A Prospective, Single-Center, Single-Arm Phase II Clinical Study","Inclusion Criteria:\n\n* a. Patients with histologically confirmed esophageal squamous cell carcinoma (ESCC) , aged 18-80 years;\n* b. Unresectable locally advanced, postoperative recurrent, or metastatic ESCC that has progressed on or is intolerant to first-line systemic therapy. For patients who received definitive concurrent chemoradiotherapy (CCRT) , disease progression during or within 6 months post-treatment is considered first-line treatment failure;\n* c. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) . All positive regional lymph nodes are counted as a single lesion, while non-regional metastatic lymph nodes are counted per station;\n* d. Adequate major organ function, defined as:\n\n  1. Hematology:\n\n     1. Hemoglobin (Hb) ≥ 90 g\u002FL\n     2. White blood cell (WBC) count ≥ 1.5 × 10⁹\u002FL\n     3. Platelet count ≥ 60 × 10⁹\u002FL\n  2. Serum biochemistry:\n\n     1. Albumin ≥ 25 g\u002FL\n     2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN)\n     3. Total bilirubin ≤ 1.5 × ULN\n     4. Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 60 mL\u002Fmin\n  3. Echocardiography:\n\nLeft ventricular ejection fraction (LVEF) ≥ 50% (lower limit of normal)\n\n* e. Eastern Cooperative Oncology Group (ECOG) performance status: 0-2;\n* f. Expected survival ≥ 3 months;\n* g. Voluntarily enrolled, with signed informed consent, and willing to comply with study protocols and follow-up.\n\nExclusion Criteria:\n\n* a. Patients with severe organ dysfunction, uncontrolled acute infection, or significant comorbidities;\n* b. Patients with vertebral metastases accompanied by spinal cord compression symptoms;\n* c. Patients with esophagotracheal or esophagomediastinal fistulas;\n* d. Patients with uncontrolled pleural, pericardial, or pelvic effusions requiring repeated drainage;\n* e. Patients with esophageal primary\u002Fmetastatic lesions invading the heart or great vessels, as assessed by the responsible physician, with a risk of life-threatening hemorrhage;\n* f. Patients with esophageal primary\u002Fmetastatic lesions invading the trachea or bronchi, as assessed by the responsible physician, with a risk of esophagotracheal fistula;\n* g. Patients not suitable for short-course hypofractionated radiotherapy, as evaluated by the responsible physician;\n* h. Pregnant or lactating women;\n* i. Patients with mental disorders, or those with a history of psychotropic drug abuse and unable to quit;\n* j. Patients who have participated in other drug clinical trials within the past 4 weeks;\n* k. Patients or their families who refuse to participate in the study.","ALL","18 Years","80 Years",{"count":84,"type":85},37,"ESTIMATED","INTERVENTIONAL",[88],"PHASE2","In the era of immunotherapy, the standard second-line treatment regimen for locally advanced\u002Fmetastatic esophageal squamous cell carcinoma (ESCC) remains controversial. This prospective, single-center, single-arm phase II clinical study aims to evaluate the efficacy and safety of Ivonescimab combined with short-course hypofractionated radiotherapy as a second-line therapy for patients with locally advanced\u002Fmetastatic ESCC. The study plans to enroll 37 patients who have failed first-line treatment, without grouping, all of whom will receive Ivonescimab combined with short-course hypofractionated radiotherapy. The primary endpoints are progression-free survival (PFS) and safety, while the secondary endpoints include overall survival (OS), duration of response (DOR), and objective response rate (ORR). The study duration is 2 years.",[91],"Esophageal Squamous Cell Carcinoma",[93,94,95],"Esophageal cancer","Hypofractionated Radiotherapy","Ivonescimab","2025-09-16",{"date":98,"type":99},"2025-09-23","ACTUAL",{"date":101,"type":99},"2025-07-01",{"date":103,"type":85},"2027-06-30",{"name":5,"class":6},1]