Esophageal Squamous Cell Carcinoma (ESCC)NCT07705412
Postoperative Radiotherapy and Lymph Node Dissection After Neoadjuvant Immunochemotherapy for Esophageal Squamous Cell Carcinoma
An observational study of Esophageal Squamous Cell Carcinoma (ESCC), run by Tongji Hospital at 1 site in China.
Trial summary
This is a multicenter, retrospective observational study using existing medical records of patients with esophageal squamous cell carcinoma who received at least two cycles of neoadjuvant immunochemotherapy followed by curative surgery with complete tumor removal and negative surgical margins between January 2021 and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma (ESCC)
- What is being tested?
- Postoperative Radiotherapy and Lymph Node Dissection
- Type of treatment
- Surgery or procedure
- How many people
- 465 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 30 Jun 2026
- 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: The study population will be selected from the electronic medical record and hospital information system databases of six esophageal cancer centers. Consecutive patients treated between January 2021 and December 2024 will be screened. Eligible patients will have histologically confirmed esophageal squamous cell carcinoma and will have received neoadjuvant immunochemotherapy followed by curative esophagectomy with R0 resection. Existing demographic, clinical, surgical, pathological, postoperative treatment, and follow-up data will be retrospectively extracted. No treatment or exposure will be assigned by the investigators. All eligible patients will be included in one retrospective cohort, with postoperative radiotherapy and lymph node dissection characteristics evaluated as observed clinical exposures.
Who may be able to join
- Histologically confirmed esophageal squamous cell carcinoma.
- Received at least two cycles of neoadjuvant immunochemotherapy consisting of a PD-1 or PD-L1 inhibitor combined with platinum- and taxane-based chemotherapy.
- Underwent planned curative esophagectomy with R0 resection, defined as microscopically negative surgical margins.
- Operative records and postoperative pathology reports documented the number of lymph nodes removed.
- Complete information on postoperative management was available, including postoperative radiotherapy, systemic therapy, or observation. For patients who received postoperative radiotherapy, information on the radiation field and dose was available.
- At least 12 months of postoperative follow-up information was available.
Who cannot join
- Histological type other than esophageal squamous cell carcinoma, including adenocarcinoma or neuroendocrine carcinoma.
- Received neoadjuvant chemoradiotherapy, neoadjuvant immunochemoradiotherapy, neoadjuvant chemotherapy alone, or no neoadjuvant treatment.
- Distant metastatic disease at the initial diagnosis.
- Underwent R1 or R2 resection.
- Death within 90 days after surgery.
- History of another malignancy within 5 years before study entry, except for cured nonmelanoma skin cancer or carcinoma in situ, or a history of thoracic radiotherapy.
- Missing key information required to determine the extent of lymph node dissection, postoperative radiotherapy details, date of recurrence, or date of death.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Postoperative Radiotherapy and Lymph Node Dissection on Recurrence and Distant Metastasis After Neoadjuvant Immunochemotherapy and R0 Resection for Esophageal Squamous Cell Carcinoma: A Multicenter Retrospective Real-World Study
This is a multicenter, retrospective observational study using existing medical records of patients with esophageal squamous cell carcinoma who received at least two cycles of neoadjuvant immunochemotherapy followed by curative surgery with complete tumor removal and negative surgical margins between January 2021 and December 2024.
The main aim of this study is to evaluate whether postoperative radiotherapy is associated with better control of cancer recurrence in the surgical area and regional lymph nodes, and whether this association differs according to the extent and number of lymph nodes removed during surgery. Patients will not be assigned to any treatment as part of this study. Outcomes will be compared according to postoperative radiotherapy status and lymph node dissection characteristics.
The primary outcome is locoregional recurrence-free survival. Secondary outcomes include disease-free survival, overall survival, and distant metastasis-free survival. Clinical, surgical, pathological, treatment, and follow-up information will be collected from electronic medical records at six esophageal cancer centers. Approximately 300 patients are expected to be included.
- Being tested
- Postoperative Radiotherapy, Lymph Node Dissection
- 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.
Postoperative RadiotherapyRadiation
Receipt or nonreceipt of postoperative radiotherapy after R0 esophagectomy was determined during routine clinical care and was not assigned by the study protocol. Information on radiotherapy dose, target volume, treatment schedule, and completion status will be extracted from existing medical records.
Lymph Node DissectionProcedure or surgery
Lymph node dissection performed during curative esophagectomy will be evaluated according to the documented anatomical extent of dissection and the number of lymph nodes removed. The surgical procedure was determined during routine clinical care and was not assigned by the study protocol.
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional Recurrence-Free Survival (LRFS)
Measured: From the date of surgery to locoregional recurrence, death, or the last available follow-up, assessed up to 5 years after surgery
Secondary outcomes (3)
Disease-Free Survival (DFS)
Disease-free survival is defined as the time from the date of surgery to the first occurrence of locoregional recurrence, distant metastasis, or death from any cause, whichever occurs first. Participants without an event will be censored at the date of the last available follow-up.
Measured: From the date of surgery to disease recurrence, death, or the last available follow-up, assessed up to 5 years after surgery
Overall Survival (OS)
Overall survival is defined as the time from the date of surgery to death from any cause. Participants who are alive will be censored at the date of the last confirmed follow-up.
Measured: From the date of surgery to death or the last confirmed follow-up, assessed up to 5 years after surgery
Distant Metastasis-Free Survival (DMFS)
Distant metastasis-free survival is defined as the time from the date of surgery to the first occurrence of distant metastasis or death from any cause, whichever occurs first. Distant metastasis refers to disease recurrence outside the locoregional area. Participants without an event will be censored at the date of the last available follow-up.
Measured: From the date of surgery to distant metastasis, death, or the last available follow-up, assessed up to 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Sep 2025
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
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.
- 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
- 465 participants (actual)
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
- NCT07705412
- Sponsor's protocol ID
- TJ-IRB202512010
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2026
- Last updated
- 15 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 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Postoperative Radiotherapy and Lymph Node Dissection on Recurrence and Distant Metastasis After Neoadjuvant Immunochemotherapy and R0 Resection for Esophageal Squamous Cell Carcinoma: A Multicenter Retrospective Real-World Study
- ClinicalTrials.gov ID
- NCT07705412
- Acronym / sponsor ID
- TJ-IRB202512010
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 465 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 15 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 multicenter, retrospective observational study using existing medical records of patients with esophageal squamous cell carcinoma who received at least two cycles of neoadjuvant immunochemotherapy followed by curative surgery with complete tumor removal and negative surgical margins between January 2021 and December 2024.
The main aim of this study is to evaluate whether postoperative radiotherapy is associated with better control of cancer recurrence in the surgical area and regional lymph nodes, and whether this association differs according to the extent and number of lymph nodes removed during surgery. Patients will not be assigned to any treatment as part of this study. Outcomes will be compared according to postoperative radiotherapy status and lymph node dissection characteristics.
The primary outcome is locoregional recurrence-free survival. Secondary outcomes include disease-free survival, overall survival, and distant metastasis-free survival. Clinical, surgical, pathological, treatment, and follow-up information will be collected from electronic medical records at six esophageal cancer centers. Approximately 300 patients are expected to be included.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be selected from the electronic medical record and hospital information system databases of six esophageal cancer centers. Consecutive patients treated between January 2021 and December 2024 will be screened. Eligible patients will have histologically confirmed esophageal squamous cell carcinoma and will have received neoadjuvant immunochemotherapy followed by curative esophagectomy with R0 resection. Existing demographic, clinical, surgical, pathological, postoperative treatment, and follow-up data will be retrospectively extracted. No treatment or exposure will be assigned by the investigators. All eligible patients will be included in one retrospective cohort, with postoperative radiotherapy and lymph node dissection characteristics evaluated as observed clinical exposures.
Key inclusion criteria (6 listed)
- Histologically confirmed esophageal squamous cell carcinoma.
- Received at least two cycles of neoadjuvant immunochemotherapy consisting of a PD-1 or PD-L1 inhibitor combined with platinum- and taxane-based chemotherapy.
- Underwent planned curative esophagectomy with R0 resection, defined as microscopically negative surgical margins.
- Operative records and postoperative pathology reports documented the number of lymph nodes removed.
- Complete information on postoperative management was available, including postoperative radiotherapy, systemic therapy, or observation. For patients who received postoperative radiotherapy, information on the radiation field and dose was available.
Key exclusion criteria (7 listed)
- Histological type other than esophageal squamous cell carcinoma, including adenocarcinoma or neuroendocrine carcinoma.
- Received neoadjuvant chemoradiotherapy, neoadjuvant immunochemoradiotherapy, neoadjuvant chemotherapy alone, or no neoadjuvant treatment.
- Distant metastatic disease at the initial diagnosis.
- Underwent R1 or R2 resection.
- Death within 90 days after surgery.
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 |
|---|---|---|
| Postoperative RadiotherapyReceipt or nonreceipt of postoperative radiotherapy after R0 esophagectomy was determined during routine clinical care and was not assigned by the study protocol. Information on radiotherapy dose, target volume, treatment schedule, and completion status will be extracted from existing medical records. | Radiation | – |
| Lymph Node DissectionLymph node dissection performed during curative esophagectomy will be evaluated according to the documented anatomical extent of dissection and the number of lymph nodes removed. The surgical procedure was determined during routine clinical care and was not assigned by the study protocol. | Procedure or surgery | – |
Primary outcome
Locoregional Recurrence-Free Survival (LRFS)
Time frame: From the date of surgery to locoregional recurrence, death, or the last available follow-up, assessed up to 5 years after surgery
3 secondary outcomes
Disease-Free Survival (DFS)
Time frame: From the date of surgery to disease recurrence, death, or the last available follow-up, assessed up to 5 years after surgery
Overall Survival (OS)
Time frame: From the date of surgery to death or the last confirmed follow-up, assessed up to 5 years after surgery
Distant Metastasis-Free Survival (DMFS)
Time frame: From the date of surgery to distant metastasis, death, or the last available follow-up, assessed up to 5 years after surgery
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 15 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Squamous Cell Carcinoma (ESCC), run by Tongji Hospital 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 6 inclusion and 7 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 15 Jul 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?
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?
Locoregional Recurrence-Free Survival (LRFS) (time frame: From the date of surgery to locoregional recurrence, death, or the last available follow-up, assessed up to 5 years after surgery). 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 15 Jul 2026.