Clinical trial · Observational
Risk of Esophageal Cancer Returning After Immunotherapy, Chemotherapy, and Surgery
Postoperative Recurrence Risk and Associated Factors in Patients With Esophageal Squamous Cell Carcinoma After Neoadjuvant Immunochemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
This observational study aims to understand the risk of cancer returning after surgery in people with esophageal squamous cell carcinoma, a type of cancer of the food pipe. It focuses on people who received immunotherapy and chemotherapy before surgery. Researchers will review existing medical records, scans, reports on tissue removed during surgery, and follow-up information. They will examine when and where cancer returns and which patient characteristics, treatment details, scan findings, and tissue findings are associated with its return. All treatment and tests were part of routine care. The study does not assign treatment or require additional scans, tissue collection, or follow-up visits.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma (ESCC) | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- ESCC After Neoadjuvant Immunochemotherapy and Surgery
- description
- Patients with histologically confirmed esophageal squamous cell carcinoma who underwent curative esophagectomy between August 1, 2020, and October 31, 2025, after neoadjuvant immunochemotherapy. Existing clinical records, FDG PET/CT findings, surgical pathology reports, and postoperative follow-up records will be reviewed to assess recurrence risk and associated factors. All treatments and examinations were provided as part of routine clinical care and were not assigned by this study.
Primary outcomes (1)
- measure
- Recurrence-Free Survival
- timeFrame
- From surgery through December 1, 2025, up to 64 months.
- description
- Time, in months, from surgery to the first documented local, regional, or distant recurrence, determined using imaging, pathology, or documented clinical assessment. Participants without recurrence will be censored at their last disease assessment. Death without documented recurrence is not an RFS event; these participants will be censored at their last disease assessment before death. RFS probabilities at 12 and 24 months after surgery will be estimated using the Kaplan-Meier method.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older at the time of surgery. Histologically confirmed esophageal squamous cell carcinoma. Receipt of neoadjuvant immunochemotherapy, defined as an immune checkpoint inhibitor combined with chemotherapy, followed by curative esophagectomy between August 1, 2020, and October 31, 2025. Microscopically negative surgical margins (R0 resection), postoperative M0 status confirmed on review using the American Joint Committee on Cancer eighth edition staging system, and verifiable postoperative ypT and ypN categories. Availability of FDG PET/CT performed after completion of neoadjuvant treatment and before surgery, together with a verifiable surgery date, recurrence status, and valid follow-up dates. Availability of pretreatment PET/CT is not required. Exclusion Criteria: * Histology other than esophageal squamous cell carcinoma, R1 or R2 resection. Death within 30 days after surgery or absence of any verifiable postoperative outcome follow-up. Missing essential pathological staging information, or survival data that prevent confirmation of eligibility or determination of the primary outcome despite review of source records. Missing nonessential variables alone will not result in exclusion.
References
Publications (0)
Data not yet available