Standardized Management of Esophageal Fistula in Esophageal Squamous Cell Carcinoma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorPeking University Cancer Hospital & Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients with postoperative anastomotic fistula.
Uncontrolled active bleeding.
Presence of a concurrent primary malignancy other than esophageal carcinoma.
Heart failure (NYHA Class III-IV)
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Standardized Management Protocol for Esophageal Fistula
Other interventionThis 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.
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: Standardized Management Cohort1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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).2
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.3
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).4
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).Other outcomes
1
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).2
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).3
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).Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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