NCT07353541Not yet recruiting
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 · Last updated 20 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 32 (estimated)
- First submitted
- 19 Nov 2025
- Start date
- 1 Feb 2026
- Primary completion date
- 1 Apr 2026
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07353541
What you commit to
- Study type: Observational
- Planned participants: 32
- From 1 Feb 2026 to the primary completion date, 1 Apr 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of a concurrent primary malignancy other than esophageal carcinoma.
- 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).
Other illness
- Patients with postoperative anastomotic fistula.
- Uncontrolled active bleeding.
- 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.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.