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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07533357

Enrollment

158

Registered

2026-04-16

Start date

2026-04-20

Completion date

2029-04-06

Last updated

2026-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

esophageal squamous cell carcinoma, PD 1 inhibitors, negative tumor draining lymph nodes, Tpex

Brief 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. 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
overall survival	2 years	overall survival

Outcome results