Standardized Management of Esophageal Fistula in Esophageal Squamous Cell Carcinoma

NCT07353541 | Not Yet Recruiting DMC

• 2 other identifiers: PKU-ESCC-EF-ORS-0012024YJZ21
• Study Type: observational
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Esophageal Squamous Cell Carcinoma (ESCC); Esophageal Fistula

Keywords

Esophageal Squamous Cell Carcinoma; Esophageal Fistula; Standardized Management; Stent Placement; Nutritional Support; Observational Study; Registry Study; Real-world Evidence

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Overall survival is defined as the time from the diagnosis of esophageal fistula to death from any cause

  From date of fistula diagnosis until death from any cause, assessed up to 6 months.

Secondary Outcomes (6)

• Rate of Subsequent Anti-tumor Therapy

  From date of fistula diagnosis until the initiation of subsequent anti-tumor therapy, assessed through study completion (up to 6 months).

• Fistula Sealing Success Rate

  At 2 weeks and 4 weeks after the initial fistula intervention.

• Nutritional Status (NRS 2002)

  From baseline through study completion (up to 6 months).

• Nutritional Status (PG-SGA)

  From baseline through study completion (up to 6 months).

• Quality of Life (QOL)

  From baseline through study completion (up to 6 months).

Other Outcomes (3)

• Percentage of Participants with PD-L1 Positive Expression in Tumor Tissue

  At baseline (time of fistula diagnosis).

• EGFR Expression Level in Tumor Tissue

  At baseline (time of fistula diagnosis).

• Ki-67 Proliferation Index in Tumor Tissue

  At baseline (time of fistula diagnosis).

Study Arms (1)

Standardized Management Cohort

All enrolled patients with advanced esophageal squamous cell carcinoma and newly diagnosed esophageal fistula who receive the standardized diagnosis and treatment protocol.

Other: Standardized Management Protocol for Esophageal Fistula

Interventions

Standardized Management Protocol for Esophageal Fistula OTHER

This is a comprehensive, standardized clinical management protocol for esophageal fistula in advanced esophageal squamous cell carcinoma patients. The protocol integrates multiple standardized components into a unified pathway: (1) systematic diagnosis using iodine-contrast esophagography, chest CT, and endoscopy; (2) interventional fistula sealing with covered esophageal/airway stents selected by fistula characteristics; (3) coordinated adjunctive therapy including anti-infectives, acid suppression, and negative suction; (4) mandatory nutritional assessment with early transition from parenteral to enteral feeding; and (5) a defined pathway for subsequent anti-tumor therapy after clinical recovery. This multi-modal, sequential approach differentiates it from isolated interventions by providing integrated management from diagnosis through nutritional rehabilitation to subsequent oncology care within a standardized framework.

Standardized Management Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult patients (aged 18-75 years) with unresectable, advanced esophageal squamous cell carcinoma (ESCC) who have been newly diagnosed with an esophageal fistula (tracheoesophageal or tracheomediastinal fistula). Eligible participants must have received no more than three prior lines of systemic anti-tumor therapy and must demonstrate adequate organ function and an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, making them potential candidates for subsequent anti-tumor treatment following fistula management. Patients with postoperative anastomotic leaks, other active malignancies, uncontrolled infections, significant cardiopulmonary disease, or other specified exclusion criteria will not be eligible for enrollment.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimens to be retained include peripheral blood samples for complete blood count, biochemistry, coagulation function, thyroid function, and lymphocyte subset analysis, urine samples for routine urinalysis, and esophageal tissue specimens (two biopsies collected from the peri-fistula region during endoscopic procedures) for histopathological examination and biomarker profiling (EGFR, PD-L1, Ki67). All specimens will be collected, processed, and stored under standardized protocols by qualified investigators and clinical staff.

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma; Esophageal Fistula

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Fistula; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Zhihao Lu

CONTACT

+85201088196561; pppeirain@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: January 20, 2026
• Study Start: February 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2025-12