[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607403":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":18,"centralContacts":19,"locations":25,"responsibleParty":40,"collaborators":18,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":18,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":18,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":28,"whyStopped":18,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Anhui Provincial Hospital","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Drug: Ivonescimab+Radiotherapy",[15],{"type":16,"name":9,"description":11,"armGroupLabels":17,"otherNames":18},"DRUG",[9],null,[20],{"name":21,"role":22,"phone":23,"phoneExt":18,"email":24},"Huiquan Liu","CONTACT","+86 15005518171","759821691@qq.com",[26],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":18},"Anhui Provincal Hospital","RECRUITING","Hefei","Anhui","230000","China","CN",{"type":35,"coordinates":36},"Point",[37,38],117.28083,31.86389,{"lat":38,"lon":37},{"type":41,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100607403","phase-2-ivonescimab-plus-short-course-hypofractionated-radiotherapy-as-second-line-therapy-for-esophageal-squamous-cell-carcinoma-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":53,"type":54},37,"ESTIMATED","INTERVENTIONAL",[57],"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.",[60],"Esophageal Squamous Cell Carcinoma",[62,63,64],"Esophageal cancer","Hypofractionated Radiotherapy","Ivonescimab","2025-09-16",{"date":67,"type":68},"2025-09-23","ACTUAL",{"date":70,"type":68},"2025-07-01",{"date":72,"type":54},"2027-06-30",{"name":5,"class":6},1]