Esophageal Cancer
Conditions
Keywords
esophageal squamous cell carcinoma, PD 1 inhibitors, negative tumor draining lymph nodes, Tpex, pCR
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 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.
Interventions
None listed
Sponsors
Fudan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pCR rate | From enrollment to the surgery | pathologic complete response rate |
Outcome results
None listed