Esophageal CancerNCT07533357
Tpex Subsets in Negative Tumor Draining Lymph Nodes for Predicting the Efficacy of PD 1 Inhibitors in Advanced or Recurrent Esophageal Squamous Cell Carcinoma
An observational study of Esophageal Cancer, run by Fudan University.
Trial summary
The goal of this observational study is to to determine whether patients with a high proportion of precursor exhausted T cells (Tpex) in negative tumor draining lymph nodes have longer overall survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- How many people
- 158 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2026to 6 Apr 2029
- 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: Advanced or recurrent esophageal squamous cell carcinoma patients
Who may be able to join
- Aged ≥18 years
- Histologically confirmed esophageal carcinoma
- Clinical stages IV based on the 8th AJCC TNM classification, or recurrent esophageal cancer
- plan to treated with PD-1 immunotherapy
- Eastern Cooperative Oncology Group(ECOG) performance status: 0-2
Who cannot join
- Esophageal perforation or hematemesis
- Any active autoimmune disease or a history of autoimmune disease
- Disease progression occurs within 3months after PD-1 immunotherapy.
- Allergic to macromolecular protein preparations, or to any of the ingredients in PD-1 inhibitors for injection.
- Uncontrolled heart diseases or clinical symptoms
- Congenital or acquired immunodeficiency (such as HIV infection); active hepatitis B (HBV-DNA≥104 copy number/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method); active tuberculosis.
About this study
Official title: A Prospective Study of Tpex Subsets in Negative Tumor Draining Lymph Nodes for Predicting the Efficacy of PD 1 Inhibitors in Advanced or Recurrent Esophageal Squamous Cell Carcinoma
The goal of this observational study is to to determine whether patients with a high proportion of precursor exhausted T cells (Tpex) in negative tumor draining lymph nodes have longer overall survival. The main question it aims to answer is: Whether precursor exhausted T cells (Tpex) in negative tumor-draining lymph nodes have better predictive efficacy for treatment response than PD-L1 CPS.
- Conditions
- Esophageal Cancer
- Keywords
- esophageal squamous cell carcinoma, PD 1 inhibitors, negative tumor draining lymph nodes, Tpex
- Medical subject headings
- Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma
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 |
|---|---|---|
| PD-1 treatment group | PD-1 treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
overall survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completion6 Apr 2029 (estimated)
- Study completion6 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuai Le Zhao, MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533357
- Sponsor's protocol ID
- ESO-shanghai 30a
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2026
- Last updated
- 16 Apr 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 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Tpex Subsets in Negative Tumor Draining Lymph Nodes for Predicting the Efficacy of PD 1 Inhibitors in Advanced or Recurrent Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07533357
- Acronym / sponsor ID
- ESO-shanghai 30a
- Conditions
- Esophageal Cancer
- Keywords
- esophageal squamous cell carcinoma, PD 1 inhibitors, negative tumor draining lymph nodes, Tpex
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 6 Apr 2029 (estimated)
- Study completion
- 6 Apr 2029 (estimated)
- First posted
- 16 Apr 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.
The goal of this observational study is to to determine whether patients with a high proportion of precursor exhausted T cells (Tpex) in negative tumor draining lymph nodes have longer overall survival. The main question it aims to answer is: Whether precursor exhausted T cells (Tpex) in negative tumor-draining lymph nodes have better predictive efficacy for treatment response than PD-L1 CPS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD-1 treatment group | – | –PD-1 treatment group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced or recurrent esophageal squamous cell carcinoma patients
Key inclusion criteria (5 listed)
- Aged ≥18 years
- Histologically confirmed esophageal carcinoma
- Clinical stages IV based on the 8th AJCC TNM classification, or recurrent esophageal cancer
- plan to treated with PD-1 immunotherapy
- Eastern Cooperative Oncology Group(ECOG) performance status: 0-2
Key exclusion criteria (6 listed)
- Esophageal perforation or hematemesis
- Any active autoimmune disease or a history of autoimmune disease
- Disease progression occurs within 3months after PD-1 immunotherapy.
- Allergic to macromolecular protein preparations, or to any of the ingredients in PD-1 inhibitors for injection.
- Uncontrolled heart diseases or clinical symptoms
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: 2 years
overall survival
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 Apr 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 Cancer, run by Fudan 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 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: opening soon, as of the sponsor's last update on 16 Apr 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?
overall survival (time frame: 2 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 16 Apr 2026.