[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"esophageal-fistula\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:esophageal-fistula":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100620124","standardized-management-of-esophageal-fistula-in-esophageal-squamous-cell-carcinoma-100620124",false,"NCT07353541","Standardized Management of Esophageal Fistula in Esophageal Squamous Cell Carcinoma","An Evaluation of the Safety and Efficacy of a Standardized Diagnosis and Treatment Protocol for Esophageal Fistula in Patients With Esophageal Squamous Cell Carcinoma: A Single-Arm, Multi-Center Clinical Study","PKU-ESCC-EF","Inclusion Criteria:\n\n* Voluntary participation and provision of written informed consent.\n* Age between 18 and 75 years (inclusive).\n* Histologically confirmed diagnosis of esophageal squamous cell carcinoma.\n* Radiologically confirmed unresectable, advanced disease.\n* Newly diagnosed esophageal fistula (including tracheoesophageal fistula or mediastinal esophageal fistula).\n* Previous receipt of ≤ 3 lines of systemic anti-tumor therapy.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Adequate organ and marrow function within 7 days prior to potential anti-tumor treatment, as defined by:\n* Hemoglobin ≥ 9.0 g\u002FdL\n* Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL\n* Platelet count ≥ 100 × 10⁹\u002FL\n* Total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN)\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (or ≤ 5 × ULN in the presence of liver metastases)\n* Serum creatinine ≤ 1.5 × ULN\n* Adequate cardiac, pulmonary, and renal function to be eligible for general anesthesia, with no contraindications to general anesthesia.\n\nExclusion Criteria:\n\n* Patients with postoperative anastomotic fistula.\n* Uncontrolled active bleeding.\n* Presence of a concurrent primary malignancy other than esophageal carcinoma.\n* Clinically significant cardiovascular disease, including but not limited to:\n* Heart failure (NYHA Class III-IV)\n* Uncontrolled coronary artery disease, cardiomyopathy, or arrhythmia\n* Uncontrolled hypertension\n* History of myocardial infarction within the past 1 year\n* Neurological or psychiatric disorders that impair cognitive ability, including the presence of central nervous system metastases.\n* Uncontrolled, active severe clinical infection ( \\> Grade 2 per NCI-CTCAE version 5.0) within 14 days prior to enrollment, including active tuberculosis (this is a contraindication for anti-tumor therapy, not for interventional procedures).\n* Known or self-reported HIV infection, or active Hepatitis B or Hepatitis C.\n* A history of interstitial lung disease (e.g., interstitial pneumonia, pulmonary fibrosis), or evidence of interstitial lung disease on baseline chest X-ray\u002FCT.","ALL","18 Years","75 Years",{"count":21,"type":22},32,"ESTIMATED","6 Months","OBSERVATIONAL","This prospective, multi-center, observational registry study (PKU-ESCC-EF) aims to evaluate the safety and effectiveness of a standardized diagnosis and treatment protocol for esophageal fistula (EF) in patients with advanced esophageal squamous cell carcinoma (ESCC). Esophageal fistula is a severe complication that often leads to life-threatening infections and poor nutrition. This study will observe patients receiving a comprehensive management strategy, which includes fistula sealing with esophageal or airway stents, targeted anti-infective therapy, nutritional support, and subsequent systemic anti-tumor therapy. The primary goal is to assess whether this standardized approach can improve overall survival and enable more patients to receive further anti-cancer treatments.",[27,28],"Esophageal Squamous Cell Carcinoma (ESCC)","Esophageal Fistula",[30,28,31,32,33,34,35,36],"Esophageal Squamous Cell Carcinoma","Standardized Management","Stent Placement","Nutritional Support","Observational Study","Registry Study","Real-world Evidence","NOT_YET_RECRUITING","2026-01-18",{"date":40,"type":41},"2026-01-20","ACTUAL",{"date":43,"type":22},"2026-02-01",{"date":45,"type":22},"2026-04-01",{"name":47,"class":48},"Peking University Cancer Hospital & Institute","OTHER"]