Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Fistula | — | UNRESOLVED | — |
| Esophageal Squamous Cell Carcinoma (ESCC) | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standardized Management Protocol for Esophageal Fistula | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Standardized Management Cohort
- description
- All enrolled patients with advanced esophageal squamous cell carcinoma and newly diagnosed esophageal fistula who receive the standardized diagnosis and treatment protocol.
- interventionNames
- Other: Standardized Management Protocol for Esophageal Fistula
Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- From date of fistula diagnosis until death from any cause, assessed up to 6 months.
- description
- Overall survival is defined as the time from the diagnosis of esophageal fistula to death from any cause
Secondary outcomes (6)
- measure
- Rate of Subsequent Anti-tumor Therapy
- timeFrame
- From date of fistula diagnosis until the initiation of subsequent anti-tumor therapy, assessed through study completion (up to 6 months).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Voluntary participation and provision of written informed consent. * Age between 18 and 75 years (inclusive). * Histologically confirmed diagnosis of esophageal squamous cell carcinoma. * Radiologically confirmed unresectable, advanced disease. * Newly diagnosed esophageal fistula (including tracheoesophageal fistula or mediastinal esophageal fistula). * Previous receipt of ≤ 3 lines of systemic anti-tumor therapy. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * Adequate organ and marrow function within 7 days prior to potential anti-tumor treatment, as defined by: * Hemoglobin ≥ 9.0 g/dL * Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L * Platelet count ≥ 100 × 10⁹/L * Total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (or ≤ 5 × ULN in the presence of liver metastases) * Serum creatinine ≤ 1.5 × ULN * Adequate cardiac, pulmonary, and renal function to be eligible for general anesthesia, with no contraindications to general anesthesia. Exclusion Criteria: * Patients with postoperative anastomotic fistula. * Uncontrolled active bleeding. * Presence of a concurrent primary malignancy other than esophageal carcinoma. * Clinically significant cardiovascular disease, including but not limited to: * Heart failure (NYHA Class III-IV) * Uncontrolled coronary artery disease, cardiomyopathy, or arrhythmia * Uncontrolled hypertension * History of myocardial infarction within the past 1 year * Neurological or psychiatric disorders that impair cognitive ability, including the presence of central nervous system metastases. * 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). * Known or self-reported HIV infection, or active Hepatitis B or Hepatitis C. * A history of interstitial lung disease (e.g., interstitial pneumonia, pulmonary fibrosis), or evidence of interstitial lung disease on baseline chest X-ray/CT.
References
Publications (0)
Data not yet available