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NCT Number: NCT07533357

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.

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Key information

Conditions

Esophageal Cancer Carcinoma Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Esophageal Squamous Cell Carcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. overall survival

    Time frame: 2 years

    overall survival

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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