Tpex Subsets in Negative Tumor Draining Lymph Nodes for Predicting the Efficacy of PD 1 Inhibitors in Advanced or Recurrent Esophageal Squamous Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Esophageal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Primary outcome measures
- overall survival [Time frame: 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07533357 · ESO-shanghai 30a