Esophageal Squamous Cell CarcinomaNCT07902544
Station-Specific Lymph Node Metastasis After Neoadjuvant Chemoimmunotherapy for Middle Thoracic Esophageal Squamous Cell Carcinoma
An observational study of Esophageal Squamous Cell Carcinoma and Esophageal Neoplasms, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.
Trial summary
Neoadjuvant chemoimmunotherapy (NCIT) is increasingly used for locally advanced esophageal squamous cell carcinoma (ESCC). However, the station-specific distribution of residual lymph node metastasis after NCIT remains incompletely characterized, and whether a pathologic complete response of the primary tumor implies… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms, Metastasis
- How many people
- 717 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 with EC who attended the Department of Thoracic Surgery at Daping Hospital and underwent the McKeown MIE procedure performed by the same surgical team were included for evaluation from Jun 2012 to Jun 2025.
Who may be able to join
- Age 18 years or older at the time of surgery.
- Tumor located in the middle thoracic esophagus.
- Histologically confirmed esophageal squamous cell carcinoma.
- Esophagectomy with lymphadenectomy performed.
- At least 15 lymph nodes dissected and examined.
- Surgery performed at the study center between June 2012 and June 2025.
Who cannot join
- Adenocarcinoma, small-cell carcinoma, or other histologic subtypes.
- Concomitant malignant tumors.
- Incomplete medical records.
About this study
Neoadjuvant chemoimmunotherapy (NCIT) is increasingly used for locally advanced esophageal squamous cell carcinoma (ESCC). However, the station-specific distribution of residual lymph node metastasis after NCIT remains incompletely characterized, and whether a pathologic complete response of the primary tumor implies nodal clearance is unclear. This single-center retrospective cohort study included consecutive patients with middle thoracic ESCC who underwent esophagectomy with lymphadenectomy (at least 15 nodes retrieved) between June 2012 and June 2025. Station-specific lymph node metastasis rates were analyzed in the NCIT group (n = 272) according to residual pathologic T category (ypT), and in the upfront surgery group (n = 445) according to pathologic T category (pT). The two groups followed different clinical pathways and were not randomized; between-group comparisons are descriptive only and no causal inference is intended. The study aims to provide an anatomic basis for surgical planning and postoperative risk stratification in middle thoracic ESCC.
Read the detailed description
Regional lymph node metastasis is one of the most important prognostic determinants in esophageal cancer, and residual nodal disease after neoadjuvant therapy is associated with adverse oncologic outcomes. Primary tumor location determines the pattern of regional nodal spread, and the middle thoracic esophagus has a complex, bidirectional longitudinal lymphatic drainage. Neoadjuvant chemoimmunotherapy (NCIT) has been increasingly adopted for locally advanced ESCC, but data describing the station-specific distribution of residual nodal metastasis after NCIT remain limited.
This is a single-center retrospective cohort study. Consecutive adults with middle thoracic ESCC who underwent esophagectomy with lymphadenectomy between June 2012 and June 2025 at the Army Medical Center of PLA (Daping Hospital) were screened. Eligibility required middle thoracic tumor location, histologically confirmed ESCC, esophagectomy with lymphadenectomy, and at least 15 lymph nodes dissected. Patients with adenocarcinoma or other histologic subtypes, concomitant malignant tumors, or incomplete medical records were excluded. A total of 717 patients were included: 272 in the NCIT group and 445 in the upfront surgery group.
The NCIT group received at least one preoperative cycle, administered every 3 weeks. Chemotherapy consisted of a taxane (paclitaxel, nab-paclitaxel, or docetaxel) combined with a platinum agent (cisplatin, carboplatin, lobaplatin, or nedaplatin). Immunotherapy consisted of a programmed cell death protein 1 (PD-1) inhibitor (pembrolizumab, camrelizumab, sintilimab, tislelizumab, toripalimab, or serplulimab). Regimen selection was at the discretion of the treating physician. Patients in the upfront surgery group underwent esophagectomy without neoadjuvant therapy.
All patients underwent McKeown esophagectomy with cervical anastomosis and two-field lymphadenectomy, performed 3 to 8 weeks after the last cycle of neoadjuvant therapy in the NCIT group. Nodal stations were recorded according to the AJCC classification (2R, 2L, 4R, 4L, 7, 8U, 8M, 8L, 9, 10, 15, 16, 17, 18, 19, 20), and pT and ypT categories were assigned according to the AJCC/UICC 8th edition. Retrieved and positive nodes were counted for each station, and tumor size was measured on the resected specimen along three diameters.
The primary outcome is the station-specific lymph node metastasis rate, analyzed by residual ypT category (ypT0, ypT1, ypT2, ypT3-4) in the NCIT group and by pT category (pTis, pT1, pT2, pT3-4) in the upfront surgery group. Stations with metastasis rates above 10%, between 5% and 10%, and below 5% were classified as high-, intermediate-, and low-risk, respectively. Rates based on fewer than 20 dissected nodes are reported with caution. Continuous variables are summarized as mean and standard deviation and compared with the Student t test; categorical variables are summarized as counts and percentages and compared with the chi-square test or Fisher exact test. All tests are two-sided, with a significance level of 0.05.
Because the two cohorts were assembled on different clinical grounds and were not randomized, comparisons between residual ypT disease after NCIT and de novo pT disease after upfront surgery are descriptive and hypothesis-generating; no propensity-score matching or causal comparison was performed. This study was registered retrospectively, after completion of data collection.
- Keywords
- Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms, Middle thoracic esophageal cancer, Lymphatic Metastasis
- Medical subject headings
- Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms, Neoplasm Metastasis, Lymphatic Metastasis
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 |
|---|---|---|
| Neoadjuvant chemoimmunotherapy (NCIT) group | At least one preoperative cycle administered every 3 weeks, consisting of a taxane (paclitaxel, nab-paclitaxel, or docetaxel) plus a platinum agent (cisplatin, carboplatin, lobaplatin, or nedaplatin) plus a PD-1 inhibitor (pembrolizumab, camrelizumab, sintilimab, tislelizumab, toripalimab, or serplulimab). Regimen selection was at the treating physician's discretion. | |
| upfront surgery group | Esophagectomy with two-field lymphadenectomy without preoperative chemoimmunotherapy, in patients with relatively early-stage disease or who declined neoadjuvant therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Station-specific lymph node metastasis rate
Proportion of patients with pathologically confirmed metastasis at each AJCC lymph node station (2R, 2L, 4R, 4L, 7, 8U, 8M, 8L, 9, 10, 15, 16, 17, 18, 19, 20), reported separately by residual pathologic T category (ypT0, ypT1, ypT2, ypT3-4) in the NCIT group.
Measured: At pathologic examination of the esophagectomy specimen; surgery performed between June 2012 and June 2025.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study startJun 2012
- Primary completionJun 2025
- Study completionJun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Esophageal Squamous Cell 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
- 717 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WEI GUO, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902544
- Sponsor's protocol ID
- LNM
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared. The data are derived from a retrospective review of medical records, and the institutional ethics committee approval does not permit public deposition of patient-level data.
Publications
Sun HB, Jiang D, Liu XB, Xing WQ, Chen PN, Feng SK, Yan S. Patterns and Influence of Lymph Nodal Metastases After Neoadjuvant Chemotherapy and Surgery for Thoracic Esophageal Squamous Cell Carcinoma. Ann Surg Oncol. 2023 Aug;30(8):5205-5212. doi: 10.1245/s10434-023-13634-w. Epub 2023 May 10.
PubMed 37162643Zhou H, Lin J, Wei W, Gao P, Wang PY, Liu SY, Wang F. Frequency and distribution pattern of lymph node metastasis after neoadjuvant chemoimmunotherapy for locally advanced esophageal squamous cell carcinoma. J Cancer Res Clin Oncol. 2024 Oct 24;150(10):476. doi: 10.1007/s00432-024-05967-0.
PubMed 39448397
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Station-Specific Lymph Node Metastasis After Neoadjuvant Chemoimmunotherapy for Middle Thoracic Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07902544
- Acronym / sponsor ID
- LNM
- Keywords
- Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms, Middle thoracic esophageal cancer, Lymphatic Metastasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 717 participants (actual)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- Jun 2012 (actual)
- Primary completion
- Jun 2025 (actual)
- Study completion
- Jun 2025 (actual)
- First posted
- 29 Oct 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.
Neoadjuvant chemoimmunotherapy (NCIT) is increasingly used for locally advanced esophageal squamous cell carcinoma (ESCC). However, the station-specific distribution of residual lymph node metastasis after NCIT remains incompletely characterized, and whether a pathologic complete response of the primary tumor implies nodal clearance is unclear. This single-center retrospective cohort study included consecutive patients with middle thoracic ESCC who underwent esophagectomy with lymphadenectomy (at least 15 nodes retrieved) between June 2012 and June 2025. Station-specific lymph node metastasis rates were analyzed in the NCIT group (n = 272) according to residual pathologic T category (ypT), and in the upfront surgery group (n = 445) according to pathologic T category (pT). The two groups followed different clinical pathways and were not randomized; between-group comparisons are descriptive only and no causal inference is intended. The study aims to provide an anatomic basis for surgical planning and postoperative risk stratification in middle thoracic ESCC.
Detailed description
Regional lymph node metastasis is one of the most important prognostic determinants in esophageal cancer, and residual nodal disease after neoadjuvant therapy is associated with adverse oncologic outcomes. Primary tumor location determines the pattern of regional nodal spread, and the middle thoracic esophagus has a complex, bidirectional longitudinal lymphatic drainage. Neoadjuvant chemoimmunotherapy (NCIT) has been increasingly adopted for locally advanced ESCC, but data describing the station-specific distribution of residual nodal metastasis after NCIT remain limited.
This is a single-center retrospective cohort study. Consecutive adults with middle thoracic ESCC who underwent esophagectomy with lymphadenectomy between June 2012 and June 2025 at the Army Medical Center of PLA (Daping Hospital) were screened. Eligibility required middle thoracic tumor location, histologically confirmed ESCC, esophagectomy with lymphadenectomy, and at least 15 lymph nodes dissected. Patients with adenocarcinoma or other histologic subtypes, concomitant malignant tumors, or incomplete medical records were excluded. A total of 717 patients were included: 272 in the NCIT group and 445 in the upfront surgery group.
The NCIT group received at least one preoperative cycle, administered every 3 weeks. Chemotherapy consisted of a taxane (paclitaxel, nab-paclitaxel, or docetaxel) combined with a platinum agent (cisplatin, carboplatin, lobaplatin, or nedaplatin). Immunotherapy consisted of a programmed cell death protein 1 (PD-1) inhibitor (pembrolizumab, camrelizumab, sintilimab, tislelizumab, toripalimab, or serplulimab). Regimen selection was at the discretion of the treating physician. Patients in the upfront surgery group underwent esophagectomy without neoadjuvant therapy.
All patients underwent McKeown esophagectomy with cervical anastomosis and two-field lymphadenectomy, performed 3 to 8 weeks after the last cycle of neoadjuvant therapy in the NCIT group. Nodal stations were recorded according to the AJCC classification (2R, 2L, 4R, 4L, 7, 8U, 8M, 8L, 9, 10, 15, 16, 17, 18, 19, 20), and pT and ypT categories were assigned according to the AJCC/UICC 8th edition. Retrieved and positive nodes were counted for each station, and tumor size was measured on the resected specimen along three diameters.
The primary outcome is the station-specific lymph node metastasis rate, analyzed by residual ypT category (ypT0, ypT1, ypT2, ypT3-4) in the NCIT group and by pT category (pTis, pT1, pT2, pT3-4) in the upfront surgery group. Stations with metastasis rates above 10%, between 5% and 10%, and below 5% were classified as high-, intermediate-, and low-risk, respectively. Rates based on fewer than 20 dissected nodes are reported with caution. Continuous variables are summarized as mean and standard deviation and compared with the Student t test; categorical variables are summarized as counts and percentages and compared with the chi-square test or Fisher exact test. All tests are two-sided, with a significance level of 0.05.
Because the two cohorts were assembled on different clinical grounds and were not randomized, comparisons between residual ypT disease after NCIT and de novo pT disease after upfront surgery are descriptive and hypothesis-generating; no propensity-score matching or causal comparison was performed. This study was registered retrospectively, after completion of data collection.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant chemoimmunotherapy (NCIT) group | – | –At least one preoperative cycle administered every 3 weeks, consisting of a taxane (paclitaxel, nab-paclitaxel, or docetaxel) plus a platinum agent (cisplatin, carboplatin, lobaplatin, or nedaplatin) plus a PD-1 inhibitor (pembrolizumab, camrelizumab, sintilimab, tislelizumab, toripalimab, or serplulimab). Regimen selection was at the treating physician's discretion. |
| upfront surgery group | – | –Esophagectomy with two-field lymphadenectomy without preoperative chemoimmunotherapy, in patients with relatively early-stage disease or who declined neoadjuvant therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with EC who attended the Department of Thoracic Surgery at Daping Hospital and underwent the McKeown MIE procedure performed by the same surgical team were included for evaluation from Jun 2012 to Jun 2025.
Key inclusion criteria (6 listed)
- Age 18 years or older at the time of surgery.
- Tumor located in the middle thoracic esophagus.
- Histologically confirmed esophageal squamous cell carcinoma.
- Esophagectomy with lymphadenectomy performed.
- At least 15 lymph nodes dissected and examined.
Key exclusion criteria (3 listed)
- Adenocarcinoma, small-cell carcinoma, or other histologic subtypes.
- Concomitant malignant tumors.
- Incomplete medical records.
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
Station-specific lymph node metastasis rate
Time frame: At pathologic examination of the esophagectomy specimen; surgery performed between June 2012 and June 2025.
Proportion of patients with pathologically confirmed metastasis at each AJCC lymph node station (2R, 2L, 4R, 4L, 7, 8U, 8M, 8L, 9, 10, 15, 16, 17, 18, 19, 20), reported separately by residual pathologic T category (ypT0, ypT1, ypT2, ypT3-4) in the NCIT group.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Results publication: PubMed 37162643Sun HB, Jiang D, Liu XB, Xing WQ, Chen PN, Feng SK, Yan S. Patterns and Influence of Lymph Nodal Metastases After Neoadjuvant Chemotherapy and Surgery for Thoracic Esophageal Squamous Cell Carcinoma. Ann Surg Oncol. 2023 Aug;30(8):5205-5212. doi: 10.1245/s10434-023-13634-w. Epub 2023 May 10.
- Results publication: PubMed 39448397Zhou H, Lin J, Wei W, Gao P, Wang PY, Liu SY, Wang F. Frequency and distribution pattern of lymph node metastasis after neoadjuvant chemoimmunotherapy for locally advanced esophageal squamous cell carcinoma. J Cancer Res Clin Oncol. 2024 Oct 24;150(10):476. doi: 10.1007/s00432-024-05967-0.
- Individual participant dataSharing planned: No. No individual participant data will be shared. The data are derived from a retrospective review of medical records, and the institutional ethics committee approval does not permit public deposition of patient-level data.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Squamous Cell Carcinoma and Esophageal Neoplasms, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 29 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Station-specific lymph node metastasis rate (time frame: At pathologic examination of the esophagectomy specimen; surgery performed between June 2012 and June 2025.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07902544, which also lists 2 linked publications.
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 29 Oct 2026.