NCT07596654 The Impact of Surgical Treatment on Survival in Localized Small Cell Esophageal Cancer
| NCT ID | NCT07596654 |
| Status | Recruiting |
| Phase | — |
| Sponsor | yi shen |
| Condition | Esophageal Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 4 participants |
| Start Date | 2026-05-15 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 4 participants in total. It began in 2026-05-15 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Limited-stage small cell esophageal carcinoma (LS-SCEC) is a rare and highly aggressive malignancy with poor prognosis and no established standard treatment strategy. Due to its low incidence, current evidence is mainly derived from small retrospective studies, and the role of surgery in multimodal treatment remains controversial. In particular, the survival benefit of surgical treatment compared with definitive non-surgical therapy has not been fully clarified. This single-center retrospective cohort study aims to evaluate the impact of surgical versus non-surgical treatment strategies on survival outcomes in patients with LS-SCEC. Patients receiving surgical treatment, including surgery alone, neoadjuvant therapy followed by surgery, or surgery followed by adjuvant therapy, will be compared with patients receiving definitive non-surgical treatment, including chemoradiotherapy-based approaches. Clinical characteristics, treatment patterns, and survival outcomes will be retrospectively collected and analyzed. The primary endpoint is overall survival (OS). Secondary endpoints include progression-free survival (PFS) and treatment-related prognostic factors. Propensity score-based methods and multivariable survival analyses will be performed to reduce potential selection bias and evaluate the independent association between treatment strategy and prognosis. The study is expected to provide additional real-world evidence regarding the optimal management of LS-SCEC and help guide individualized treatment decision-making for this rare disease.
Eligibility Criteria
Inclusion Criteria: * Patients pathologically diagnosed with primary small cell esophageal carcinoma (SCEC). * Patients classified as having limited-stage disease at initial diagnosis, defined as tumor confined to the esophagus and/or regional lymph nodes without evidence of distant metastasis. * Patients who received definitive treatment at the study institution, including surgical treatment (with or without neoadjuvant or adjuvant therapy) or definitive non-surgical treatment such as chemoradiotherapy-based therapy. * Patients with complete baseline clinicopathological and treatment information available in the medical records. * Patients with available follow-up and survival outcome data. Exclusion Criteria: * Patients with extensive-stage disease or distant metastasis at diagnosis. * Patients with mixed histological subtypes in which small cell carcinoma was not the predominant component. * Patients who received palliative treatment only. * Patients with a history of other active malignant tumors within the previous 5 years. * Patients with incomplete key clinical, treatment, or follow-up data. * Patients under 18 years old.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07596654 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Esophageal Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07596654 currently recruiting?
Yes, NCT07596654 is actively recruiting participants. Contact the research team at dryishen@nju.edu.cn for enrollment information.
Where is the NCT07596654 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT07596654 clinical trial?
NCT07596654 is sponsored by yi shen. The trial plans to enroll 4 participants.