Esophageal Squamous Cell Carcinoma (ESCC)NCT07697898
TDLN-Guided Lymphadenectomy After Neoadjuvant Immunochemotherapy for ESCC
An observational study of Esophageal Squamous Cell Carcinoma (ESCC), run by Tongji Hospital.
Trial summary
This is a prospective, multicenter, observational cohort study of patients with esophageal squamous cell carcinoma who have received neoadjuvant immunochemotherapy and are scheduled to undergo curative esophagectomy with standard systematic lymphadenectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma (ESCC)
- What is being tested?
- Curative Esophagectomy With Systematic Lymphadenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 30 Jun 2031
- How long will I take part?
- 24 Months
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 to 75 years with histologically confirmed thoracic esophageal squamous cell carcinoma who have received neoadjuvant immunochemotherapy and are scheduled to undergo curative esophagectomy with standard systematic lymphadenectomy at participating centers.
Who may be able to join
- Age 18 to 75 years, regardless of sex.
- Eastern Cooperative Oncology Group performance status of 0 to 1.
- Histologically confirmed thoracic esophageal squamous cell carcinoma.
- Received neoadjuvant immunochemotherapy and considered suitable for curative surgery after multidisciplinary team evaluation.
- Clinically resectable locally advanced or locally progressive disease without evidence of distant metastasis.
- Completed preoperative contrast-enhanced computed tomography of the neck, chest, and abdomen. Positron emission tomography-computed tomography and/or endoscopic ultrasound may be performed if clinically available.
- Considered by the investigator to be able to tolerate curative esophagectomy and standard systematic lymphadenectomy.
Who cannot join
- Non-squamous cell carcinoma histology or concurrent primary malignancy requiring treatment.
- Previous curative surgery for esophageal cancer or previous radiotherapy for the current esophageal lesion.
- Evidence of distant metastasis, unresectable disease, or considered unsuitable for curative surgery after multidisciplinary team evaluation.
- Severe autoimmune disease requiring long-term systemic immunosuppressive therapy.
- Severe cardiac, pulmonary, hepatic, renal, or other major organ dysfunction that prevents surgery or completion of study-related assessments.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study, including poor compliance, inability to complete scheduled follow-up, or inability to provide key study data.
About this study
Official title: Tumor-Draining Lymph Node Preservation-Guided Intraoperative Lymphadenectomy After Neoadjuvant Immunochemotherapy for Esophageal Squamous Cell Carcinoma: A Prospective Multicenter Observational Cohort Study
This is a prospective, multicenter, observational cohort study of patients with esophageal squamous cell carcinoma who have received neoadjuvant immunochemotherapy and are scheduled to undergo curative esophagectomy with standard systematic lymphadenectomy.
The study will not alter the current standard surgical approach. All patients will receive curative esophagectomy and systematic lymph node dissection according to institutional practice. Lymph nodes will be separated and recorded by anatomical station during surgery, followed by station-level pathological assessment. Imaging findings, pathological response, perioperative outcomes, recurrence patterns, disease-free survival, overall survival, and selected immune microenvironment features will be collected and analyzed.
The purpose of this study is to characterize station-level residual lymph node metastasis risk and immune activity after neoadjuvant immunochemotherapy. The findings may help identify candidate lymph node stations for future research on individualized or lymph node-preserving surgical strategies in esophageal squamous cell carcinoma.
- Being tested
- Curative Esophagectomy With Systematic Lymphadenectomy
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curative Esophagectomy With Systematic LymphadenectomyProcedure or surgery
All participants will undergo curative esophagectomy with standard systematic lymphadenectomy according to institutional practice. The study will not intentionally reduce the extent of lymph node dissection. Lymph nodes will be separated, labeled, and recorded by anatomical station for postoperative pathological and exploratory immune microenvironment analyses.
What is being measured
The primary outcome is the main question the study is designed to answer.
2-Year Disease-Free Survival Rate
The proportion of participants who are alive without disease recurrence or distant metastasis at 2 years after curative esophagectomy. Disease-free survival is defined as the time from curative esophagectomy to the first occurrence of local recurrence, regional lymph node recurrence, distant metastasis, or death from any cause. Participants without an event will be censored at the date of last valid follow-up.
Measured: 24 months after curative esophagectomy
Secondary outcomes (5)
Overall Survival
Overall survival is defined as the time from curative esophagectomy to death from any cause. Participants who are alive will be censored at the date of last follow-up.
Measured: Up to 24 months after curative esophagectomy
2-Year Overall Survival Rate
The proportion of participants who are alive at 2 years after curative esophagectomy.
Measured: 24 months after curative esophagectomy
Locoregional Recurrence Rate
The proportion of participants who develop locoregional recurrence, including recurrence at the primary tumor bed, anastomotic region, or regional lymph nodes.
Measured: Up to 24 months after curative esophagectomy
Distant Metastasis Rate
The proportion of participants who develop distant metastasis, including metastasis to the lung, liver, bone, brain, non-regional lymph nodes, or other distant organs.
Measured: Up to 24 months after curative esophagectomy
Pattern of First Failure
The site of first recurrence or progression will be classified as local recurrence, regional recurrence, distant metastasis, or mixed recurrence.
Measured: Up to 24 months after curative esophagectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell Carcinoma (ESCC)Studies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Ni, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697898
- Sponsor's protocol ID
- TJ-IRB202606005
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor-Draining Lymph Node Preservation-Guided Intraoperative Lymphadenectomy After Neoadjuvant Immunochemotherapy for Esophageal Squamous Cell Carcinoma: A Prospective Multicenter Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07697898
- Acronym / sponsor ID
- TJ-IRB202606005
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 13 Jul 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.
This is a prospective, multicenter, observational cohort study of patients with esophageal squamous cell carcinoma who have received neoadjuvant immunochemotherapy and are scheduled to undergo curative esophagectomy with standard systematic lymphadenectomy.
The study will not alter the current standard surgical approach. All patients will receive curative esophagectomy and systematic lymph node dissection according to institutional practice. Lymph nodes will be separated and recorded by anatomical station during surgery, followed by station-level pathological assessment. Imaging findings, pathological response, perioperative outcomes, recurrence patterns, disease-free survival, overall survival, and selected immune microenvironment features will be collected and analyzed.
The purpose of this study is to characterize station-level residual lymph node metastasis risk and immune activity after neoadjuvant immunochemotherapy. The findings may help identify candidate lymph node stations for future research on individualized or lymph node-preserving surgical strategies in esophageal squamous cell carcinoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 to 75 years with histologically confirmed thoracic esophageal squamous cell carcinoma who have received neoadjuvant immunochemotherapy and are scheduled to undergo curative esophagectomy with standard systematic lymphadenectomy at participating centers.
Key inclusion criteria (7 listed)
- Age 18 to 75 years, regardless of sex.
- Eastern Cooperative Oncology Group performance status of 0 to 1.
- Histologically confirmed thoracic esophageal squamous cell carcinoma.
- Received neoadjuvant immunochemotherapy and considered suitable for curative surgery after multidisciplinary team evaluation.
- Clinically resectable locally advanced or locally progressive disease without evidence of distant metastasis.
Key exclusion criteria (6 listed)
- Non-squamous cell carcinoma histology or concurrent primary malignancy requiring treatment.
- Previous curative surgery for esophageal cancer or previous radiotherapy for the current esophageal lesion.
- Evidence of distant metastasis, unresectable disease, or considered unsuitable for curative surgery after multidisciplinary team evaluation.
- Severe autoimmune disease requiring long-term systemic immunosuppressive therapy.
- Severe cardiac, pulmonary, hepatic, renal, or other major organ dysfunction that prevents surgery or completion of study-related assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curative Esophagectomy With Systematic LymphadenectomyAll participants will undergo curative esophagectomy with standard systematic lymphadenectomy according to institutional practice. The study will not intentionally reduce the extent of lymph node dissection. Lymph nodes will be separated, labeled, and recorded by anatomical station for postoperative pathological and exploratory immune microenvironment analyses. | Procedure or surgery | – |
Primary outcome
2-Year Disease-Free Survival Rate
Time frame: 24 months after curative esophagectomy
The proportion of participants who are alive without disease recurrence or distant metastasis at 2 years after curative esophagectomy. Disease-free survival is defined as the time from curative esophagectomy to the first occurrence of local recurrence, regional lymph node recurrence, distant metastasis, or death from any cause. Participants without an event will be censored at the date of last valid follow-up.
5 secondary outcomes
Overall Survival
Time frame: Up to 24 months after curative esophagectomy
2-Year Overall Survival Rate
Time frame: 24 months after curative esophagectomy
Locoregional Recurrence Rate
Time frame: Up to 24 months after curative esophagectomy
Distant Metastasis Rate
Time frame: Up to 24 months after curative esophagectomy
Pattern of First Failure
Time frame: Up to 24 months after curative esophagectomy
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 13 Jul 2026.
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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.
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 (ESCC), run by Tongji Hospital.
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 7 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: opening soon, as of the sponsor's last update on 13 Jul 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?
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?
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?
2-Year Disease-Free Survival Rate (time frame: 24 months after curative esophagectomy). 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 13 Jul 2026.