An observational study in Esophageal Squamous Cell Carcinoma (ESCC) and Esophageal Fistula, sponsored by Peking University Cancer Hospital & Institute. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by Peking University Cancer Hospital & Institute · 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.
This observational registry employs a prospective, single-arm design to recruit eligible patients with newly diagnosed esophageal fistula (tracheoesophageal or mediastinal fistula) complicating unresectable advanced esophageal squamous cell carcinoma. All enrolled participants will receive management according to a predefined standardized diagnostic and therapeutic protocol. The protocol integrates a comprehensive workflow from diagnostic assessment to multidisciplinary intervention: initial diagnosis is supported by clinical manifestations, imaging studies, and endoscopic evaluation, followed by interventional fistula closure using esophageal or airway covered stents selected according to fistula characteristics. Accompanying medical support includes anti-infective therapy, negative pressure suction, anti-reflux treatment, and nutritional support. After achieving adequate fistula control and clinical stabilization, subsequent systemic anti-tumor therapy may be administered based on investigator assessment. Prospective data collection will encompass fistula sealing status, nutritional parameters, quality of life, subsequent anti-tumor treatment rate, overall survival, and exploratory biomarker analysis of biospecimens, thereby providing real-world evidence to standardize management strategies for this serious complication.
646 studies on the registry are indexed under Esophageal Squamous Cell Carcinoma; 275 are open to participants now.
This study's planned enrollment of 32 is below the median of 270 across 93 observational studies indexed under Esophageal Squamous Cell Carcinoma.
Browse Esophageal Squamous Cell Carcinoma studies →Peking University Cancer Hospital & Institute is the lead sponsor of 261 studies on the registry; 128 are open to participants now.
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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.
Exclusion Criteria:
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
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.
Overall Survival (OS)
Overall survival is defined as the time from the diagnosis of esophageal fistula to death from any cause
Time frame: From date of fistula diagnosis until death from any cause, assessed up to 6 months.
Rate of Subsequent Anti-tumor Therapy
The proportion of patients who successfully receive/re-initiate systemic anti-tumor therapy after fistula control and clinical recovery.
Time frame: 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
The success rate of fistula sealing, evaluated as either Complete Remission (CR) or Partial Remission (PR) according to the protocol's criteria.
Time frame: At 2 weeks and 4 weeks after the initial fistula intervention.
Nutritional Status (NRS 2002)
Nutritional risk will be assessed using the Nutritional Risk Screening 2002 (NRS 2002) tool. The total NRS 2002 score is derived from the sum of three components: Nutritional Status Impairment Score (range: 0-3 points), Disease Severity Score (range: 0-3 points), and Age Adjustment (1 point if age ≥70 years; 0 points otherwise). The total score ranges from 0 to 7 points. A higher total score indicates a greater nutritional risk (i.e., a worse outcome). In accordance with the original validation, a total score of ≥3 points is considered indicative of nutritional risk.
Time frame: From baseline through study completion (up to 6 months).
Nutritional Status (PG-SGA)
Nutritional status will be assessed using the Patient-Generated Subjective Global Assessment (PG-SGA) tool. The PG-SGA yields two primary outcomes: 1. Global Rating Categories: Patients are classified as Category A (Well nourished), Category B (Moderately malnourished or suspected of malnourishment), or Category C (Severely malnourished). 2. Total PG-SGA Score: A quantitative score is calculated from patient-generated and professional assessment components. The total score ranges from 0 to approximately 35 points. A higher score indicates a worse nutritional status and outcome (i.e., greater risk or severity of malnutrition). In clinical practice, a score of 4 or higher typically triggers the need for nutritional intervention.
Time frame: From baseline through study completion (up to 6 months).
Quality of Life (QOL)
Quality of Life will be assessed using the Functional Assessment of Cancer Therapy - Esophageal Cancer subscale (FACT-E). The FACT-E is composed of the general cancer module (FACT-G) and an esophageal cancer-specific subscale. The total score ranges from 0 to 180 points. A higher score indicates a better quality of life (i.e., a better outcome).
Time frame: From baseline through study completion (up to 6 months).
Incidence of Adverse Events (AEs)
Safety and tolerability assessed by the incidence and severity of adverse events (AEs) and serious adverse events (SAEs), graded according to NCI CTCAE v5.0.
Time frame: From the start of the standardized management protocol until 30 days after the last intervention or through study completion, whichever comes first.
Percentage of Participants with PD-L1 Positive Expression in Tumor Tissue
PD-L1 expression will be assessed in baseline tumor tissue samples via immunohistochemistry (IHC). The result will be reported as the percentage of tumor cells with positive membrane staining (e.g., using Tumor Proportion Score, TPS) and/or combined positive score (CPS), as appropriate.
Time frame: At baseline (time of fistula diagnosis).
EGFR Expression Level in Tumor Tissue
EGFR expression will be assessed in baseline tumor tissue samples via immunohistochemistry (IHC). The result will be reported using a standardized scoring system (e.g., H-score or percentage of positive cells).
Time frame: At baseline (time of fistula diagnosis).
Ki-67 Proliferation Index in Tumor Tissue
Ki-67 expression will be assessed in baseline tumor tissue samples via immunohistochemistry (IHC). The result will be reported as the Ki-67 proliferation index (percentage of positively stained tumor cell nuclei).
Time frame: At baseline (time of fistula diagnosis).
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Plan to share: Undecided
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This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Peking University Cancer Hospital & Institute