Esophageal Squamous Cell Carcinoma (ESCC)NCT07822906
Risk of Esophageal Cancer Returning After Immunotherapy, Chemotherapy, and Surgery
An observational study of Esophageal Squamous Cell Carcinoma (ESCC), run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
This observational study aims to understand the risk of cancer returning after surgery in people with esophageal squamous cell carcinoma, a type of cancer of the food pipe. It focuses on people who received immunotherapy and chemotherapy before surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma (ESCC)
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 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: The source population comprises adults who underwent esophagectomy for esophageal squamous cell carcinoma at the study institution between August 1, 2020, and October 31, 2025. Patients will be identified through institutional medical records, imaging archives, surgical and pathology registries, and existing follow-up records. All patients within this surgical window who received neoadjuvant immunochemotherapy and meet the eligibility criteria will be included. No random sampling will be performed. Documented postoperative outcomes will be reviewed through December 1, 2025.
Who may be able to join
- Age 18 years or older at the time of surgery.
- Histologically confirmed esophageal squamous cell carcinoma.
- Receipt of neoadjuvant immunochemotherapy, defined as an immune checkpoint inhibitor combined with chemotherapy, followed by curative esophagectomy between August 1, 2020, and October 31, 2025.
- Microscopically negative surgical margins (R0 resection), postoperative M0 status confirmed on review using the American Joint Committee on Cancer eighth edition staging system, and verifiable postoperative ypT and ypN categories.
- Availability of FDG PET/CT performed after completion of neoadjuvant treatment and before surgery, together with a verifiable surgery date, recurrence status, and valid follow-up dates. Availability of pretreatment PET/CT is not required.
Who cannot join
- Histology other than esophageal squamous cell carcinoma, R1 or R2 resection.
- Death within 30 days after surgery or absence of any verifiable postoperative outcome follow-up.
- Missing essential pathological staging information, or survival data that prevent confirmation of eligibility or determination of the primary outcome despite review of source records. Missing nonessential variables alone will not result in exclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
Nan Wu, Doctor, 0086-010-88121122, nanwu@bjmu.edu.cn
Nan Wu, MD
About this study
Official title: Postoperative Recurrence Risk and Associated Factors in Patients With Esophageal Squamous Cell Carcinoma After Neoadjuvant Immunochemotherapy
This observational study aims to understand the risk of cancer returning after surgery in people with esophageal squamous cell carcinoma, a type of cancer of the food pipe. It focuses on people who received immunotherapy and chemotherapy before surgery.
Researchers will review existing medical records, scans, reports on tissue removed during surgery, and follow-up information. They will examine when and where cancer returns and which patient characteristics, treatment details, scan findings, and tissue findings are associated with its return.
All treatment and tests were part of routine care. The study does not assign treatment or require additional scans, tissue collection, or follow-up visits.
- Keywords
- Neoadjuvant Immunochemotherapy, Recurrence-Free Survival, Lymph Node Metastasis
- Medical subject headings
- Esophageal Squamous Cell Carcinoma, 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 |
|---|---|---|
| ESCC After Neoadjuvant Immunochemotherapy and Surgery | Patients with histologically confirmed esophageal squamous cell carcinoma who underwent curative esophagectomy between August 1, 2020, and October 31, 2025, after neoadjuvant immunochemotherapy. Existing clinical records, FDG PET/CT findings, surgical pathology reports, and postoperative follow-up records will be reviewed to assess recurrence risk and associated factors. All treatments and examinations were provided as part of routine clinical care and were not assigned by this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-Free Survival
Time, in months, from surgery to the first documented local, regional, or distant recurrence, determined using imaging, pathology, or documented clinical assessment. Participants without recurrence will be censored at their last disease assessment. Death without documented recurrence is not an RFS event; these participants will be censored at their last disease assessment before death. RFS probabilities at 12 and 24 months after surgery will be estimated using the Kaplan-Meier method.
Measured: From surgery through December 1, 2025, up to 64 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Dec 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 Squamous Cell Carcinoma (ESCC)Studies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Nan, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822906
- Sponsor's protocol ID
- EC-2601-FF
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Recurrence Risk and Associated Factors in Patients With Esophageal Squamous Cell Carcinoma After Neoadjuvant Immunochemotherapy
- ClinicalTrials.gov ID
- NCT07822906
- Acronym / sponsor ID
- EC-2601-FF
- Keywords
- Neoadjuvant Immunochemotherapy, Recurrence-Free Survival, Lymph Node Metastasis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Sep 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 observational study aims to understand the risk of cancer returning after surgery in people with esophageal squamous cell carcinoma, a type of cancer of the food pipe. It focuses on people who received immunotherapy and chemotherapy before surgery.
Researchers will review existing medical records, scans, reports on tissue removed during surgery, and follow-up information. They will examine when and where cancer returns and which patient characteristics, treatment details, scan findings, and tissue findings are associated with its return.
All treatment and tests were part of routine care. The study does not assign treatment or require additional scans, tissue collection, or follow-up visits.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESCC After Neoadjuvant Immunochemotherapy and Surgery | – | –Patients with histologically confirmed esophageal squamous cell carcinoma who underwent curative esophagectomy between August 1, 2020, and October 31, 2025, after neoadjuvant immunochemotherapy. Existing clinical records, FDG PET/CT findings, surgical pathology reports, and postoperative follow-up records will be reviewed to assess recurrence risk and associated factors. All treatments and examinations were provided as part of routine clinical care and were not assigned by this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The source population comprises adults who underwent esophagectomy for esophageal squamous cell carcinoma at the study institution between August 1, 2020, and October 31, 2025. Patients will be identified through institutional medical records, imaging archives, surgical and pathology registries, and existing follow-up records. All patients within this surgical window who received neoadjuvant immunochemotherapy and meet the eligibility criteria will be included. No random sampling will be performed. Documented postoperative outcomes will be reviewed through December 1, 2025.
Key inclusion criteria (5 listed)
- Age 18 years or older at the time of surgery.
- Histologically confirmed esophageal squamous cell carcinoma.
- Receipt of neoadjuvant immunochemotherapy, defined as an immune checkpoint inhibitor combined with chemotherapy, followed by curative esophagectomy between August 1, 2020, and October 31, 2025.
- Microscopically negative surgical margins (R0 resection), postoperative M0 status confirmed on review using the American Joint Committee on Cancer eighth edition staging system, and verifiable postoperative ypT and ypN categories.
- Availability of FDG PET/CT performed after completion of neoadjuvant treatment and before surgery, together with a verifiable surgery date, recurrence status, and valid follow-up dates. Availability of pretreatment PET/CT is not required.
Key exclusion criteria (3 listed)
- Histology other than esophageal squamous cell carcinoma, R1 or R2 resection.
- Death within 30 days after surgery or absence of any verifiable postoperative outcome follow-up.
- Missing essential pathological staging information, or survival data that prevent confirmation of eligibility or determination of the primary outcome despite review of source records. Missing nonessential variables alone will not result in exclusion.
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
Recurrence-Free Survival
Time frame: From surgery through December 1, 2025, up to 64 months.
Time, in months, from surgery to the first documented local, regional, or distant recurrence, determined using imaging, pathology, or documented clinical assessment. Participants without recurrence will be censored at their last disease assessment. Death without documented recurrence is not an RFS event; these participants will be censored at their last disease assessment before death. RFS probabilities at 12 and 24 months after surgery will be estimated using the Kaplan-Meier method.
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 16 Sep 2026.
- Individual participant dataSharing planned: Undecided. Undecided
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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.
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 Peking University Cancer Hospital & Institute 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 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: opening soon, as of the sponsor's last update on 16 Sep 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-Free Survival (time frame: From surgery through December 1, 2025, up to 64 months.). 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 16 Sep 2026.