Esophageal CarcinomaNCT07596654
The Impact of Surgical Treatment on Survival in Localized Small Cell Esophageal Cancer
An observational study of Esophageal Carcinoma and Limited-Stage Small Cell Esophageal Carcinoma, run by yi shen at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Carcinoma, Limited-Stage Small Cell Esophageal Carcinoma
- How many people
- 4 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2026to 31 Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients pathologically diagnosed with limited-stage small cell esophageal carcinoma (LS-SCEC) who received treatment at Jinling Hospital during the study period will be retrospectively identified from institutional medical records. Eligible patients will include those who underwent surgical treatment (with or without neoadjuvant or adjuvant therapy) as well as those who received definitive non-surgical treatment, including chemoradiotherapy-based approaches. Clinical characteristics, treatment information, and follow-up data will be collected for survival analysis.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zhuangzhuang Cong, PhD contact
China1 site, 1 recruiting
- Recruiting
Jinling Hospital, Nanjing, Jiangsu Province, China.
Nanjing, Jiangsu, 210002
Zhuangzhuang Cong, PhD, +86 19962096499, czz061231007@126.com
Yi Shen, MD
About this study
Official title: The Impact of Surgical Versus Non-surgical Treatment on Survival in Localized Esophageal Small Cell Carcinoma: a Single-center Retrospective Cohort Study
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.
Read more
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.
- Keywords
- Small Cell Esophageal Carcinoma, Limited-Stage Esophageal Small Cell Carcinoma, Surgery, Chemoradiotherapy, Survival, Prognosis, Retrospective Cohort Study
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgical treatment group | Not described | |
| Non-surgical treatment group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: From the date of diagnosis until death from any cause or last follow-up, assessed up to 5 years.
Secondary outcomes (1)
progression-free survival
Measured: From the date of diagnosis until disease progression, death from any cause, or last follow-up, assessed up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start15 May 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CarcinomaStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- yi shen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, yi shen, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596654
- Sponsor's protocol ID
- 2025DZKY-023-02
- Status last verified
- Aug 2026
- First submitted
- 9 May 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Surgical Versus Non-surgical Treatment on Survival in Localized Esophageal Small Cell Carcinoma: a Single-center Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07596654
- Acronym / sponsor ID
- 2025DZKY-023-02
- Keywords
- Small Cell Esophageal Carcinoma, Limited-Stage Esophageal Small Cell Carcinoma, Surgery, Chemoradiotherapy, Survival, Prognosis, Retrospective Cohort Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- yi shenUniversity, hospital or other
- Study start
- 15 May 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 May 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment group | – | – |
| Non-surgical treatment group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients pathologically diagnosed with limited-stage small cell esophageal carcinoma (LS-SCEC) who received treatment at Jinling Hospital during the study period will be retrospectively identified from institutional medical records. Eligible patients will include those who underwent surgical treatment (with or without neoadjuvant or adjuvant therapy) as well as those who received definitive non-surgical treatment, including chemoradiotherapy-based approaches. Clinical characteristics, treatment information, and follow-up data will be collected for survival analysis.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival
Time frame: From the date of diagnosis until death from any cause or last follow-up, assessed up to 5 years.
1 secondary outcome
progression-free survival
Time frame: From the date of diagnosis until disease progression, death from any cause, or last follow-up, assessed up to 5 years.
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 6 Aug 2026.
Related trials for Esophageal Carcinoma
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
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.
Zhuangzhuang Cong, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Carcinoma and Limited-Stage Small Cell Esophageal Carcinoma, run by yi shen at 1 site in China.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Yi Shen, MD (+8613913907880, dryishen@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: From the date of diagnosis until death from any cause or last follow-up, assessed up to 5 years.). 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 6 Aug 2026.