Esophageal Squamous Cell Carcinoma (ESCC)PKU-ESCC-EFNCT07353541
Standardized Management of Esophageal Fistula in Esophageal Squamous Cell Carcinoma
An observational study of Esophageal Squamous Cell Carcinoma (ESCC) and Esophageal Fistula, run by Peking University Cancer Hospital & Institute.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma (ESCC), Esophageal Fistula
- What is being tested?
- Standardized Management Protocol for Esophageal Fistula
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Oct 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the detailed description
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.
- Being tested
- Standardized Management Protocol for Esophageal Fistula
- Keywords
- Esophageal Squamous Cell Carcinoma, Esophageal Fistula, Standardized Management, Stent Placement, Nutritional Support, Observational Study, Registry Study, Real-world Evidence
- Medical subject headings
- Esophageal Squamous Cell Carcinoma, Esophageal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Management Protocol for Esophageal FistulaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Standardized Management Protocol for Esophageal Fistula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Overall survival is defined as the time from the diagnosis of esophageal fistula to death from any cause
Measured: From date of fistula diagnosis until death from any cause, assessed up to 6 months.
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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:
- Global Rating Categories: Patients are classified as Category A (Well nourished), Category B (Moderately malnourished or suspected of malnourishment), or Category C (Severely malnourished).
- 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.
Measured: 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).
Measured: 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.
Measured: From the start of the standardized management protocol until 30 days after the last intervention or through study completion, whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell Carcinoma (ESCC)Studies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Emergency General Hospital, Beijing GoBroad Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353541
- Sponsor's protocol ID
- PKU-ESCC-EF-ORS-001
- Other IDs
- 2024YJZ21
- Acronym
- PKU-ESCC-EF
- Status last verified
- Oct 2026
- First submitted
- 19 Nov 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07353541
- Acronym / sponsor ID
- PKU-ESCC-EF / PKU-ESCC-EF-ORS-001
- Keywords
- Esophageal Squamous Cell Carcinoma, Esophageal Fistula, Standardized Management, Stent Placement, Nutritional Support, Observational Study, Registry Study, Real-world Evidence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- Emergency General Hospital, Beijing GoBroad Hospital
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standardized Management Cohort | – | Other: Standardized Management Protocol for Esophageal FistulaAll enrolled patients with advanced esophageal squamous cell carcinoma and newly diagnosed esophageal fistula who receive the standardized diagnosis and treatment protocol. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- 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).
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Management Protocol for Esophageal FistulaThis 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. | Other | Standardized Management Cohort |
Primary outcome
Overall Survival (OS)
Time frame: From date of fistula diagnosis until death from any cause, assessed up to 6 months.
Overall survival is defined as the time from the diagnosis of esophageal fistula to death from any cause
6 secondary outcomes
Rate of Subsequent Anti-tumor Therapy
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
Time frame: At 2 weeks and 4 weeks after the initial fistula intervention.
Nutritional Status (NRS 2002)
Time frame: From baseline through study completion (up to 6 months).
Nutritional Status (PG-SGA)
Time frame: From baseline through study completion (up to 6 months).
Quality of Life (QOL)
Time frame: From baseline through study completion (up to 6 months).
Incidence of Adverse Events (AEs)
Time frame: From the start of the standardized management protocol until 30 days after the last intervention or through study completion, whichever comes first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Squamous Cell Carcinoma (ESCC) and Esophageal Fistula, run by Peking University Cancer Hospital & Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhihao Lu (+85201088196561, pppeirain@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: From date of fistula diagnosis until death from any cause, assessed up to 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.