A Prospective Study of Tumor-specific Tpex in Negative Lymph Nodes for Predicting Pathological Complete Response to Neoadjuvant PD 1 Therapy in Esophageal Cancer

N/ANot Yet RecruitingNCT07573397

Fudan University88 enrolled

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 higher pCR. 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 Type

OBSERVATIONAL

Enrollment

Conditions

Esophageal Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically confirmed esophageal squamous cell carcinoma * patients eligible for surgery * plan to treated with neoadjuvant 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.

Outcomes

Primary Outcomes

pCR rate

pathologic complete response rate

Time frame: From enrollment to the surgery

Data from ClinicalTrials.gov

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