Tpex Subsets in Negative Tumor Draining Lymph Nodes for Predicting the Efficacy of PD 1 Inhibitors in Advanced or Recurrent Esophageal Squamous Cell Carcinoma

April 14, 2026 updated by: Kuai Le Zhao, MD, Fudan University

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.

Study Overview

Status

Not yet recruiting

Conditions

Esophageal Cancer

Study Type

Observational

Enrollment (Estimated)

158

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Advanced or recurrent esophageal squamous cell carcinoma patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
PD-1 treatment group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival Time Frame: 2 years	overall survival	2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 20, 2026

Primary Completion (Estimated)

April 6, 2029

Study Completion (Estimated)

April 6, 2029

Study Registration Dates

First Submitted

April 5, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)