Standardized Management of Esophageal Fistula in Esophageal Squamous Cell Carcinoma (NCT07353541) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Standardized Management of Esophageal Fistula in Esophageal Squamous Cell Carcinoma
32 participantsStarted 2026-02-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Survival (OS)
Timeframe: From date of fistula diagnosis until death from any cause, assessed up to 6 months.
Trial details
NCT IDNCT07353541
SponsorPeking University Cancer Hospital & Institute