PKU-ESCC-EF
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
Sponsor study identifier
Secondary identifiers
OTHER · Peking University Cancer Hospital
observational
32
0 countries
N/A
Study Start
February 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 19, 2025
Actual (reported)January 20, 2026
Actual (reported)February 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
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.
All enrolled patients with advanced esophageal squamous cell carcinoma and newly diagnosed esophageal fistula who receive the standardized diagnosis and treatment protocol.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
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.
First Submitted
November 19, 2025
First Posted
January 20, 2026
Study Start
February 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 1, 2026
Risk of Esophageal Cancer Returning After Immunotherapy, Chemotherapy, and Surgery
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).
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).
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 20, 2026
Record last verified: 2025-12
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Source: ClinicalTrials.gov.
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