About this trial
200 patients with advanced esophageal cancer who received PD-1 monoclonal antibody treatment would be enrolled in this study. Changes in peripheral blood immune cells before and after treatment would be recorded and used for machine learning to establish a prediction model for the efficacy of PD-1 monoclonal antibody treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with metastatic advanced esophageal squamous cell carcinoma (stage IV) confirmed by histology or cytology who are ready to receive PD-1 monoclonal antibody combined with TP chemotherapy regimen.
Eastern Cooperative Oncology Group (ECOG) performance status score between 0 and 2.
Have measurable lesions.
Expected survival > 3 months.
Disqualifiers
Have active, or have had an autoimmune disease that is likely to recur (eg, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, vasculitis, psoriasis, etc.) or at risk (e.g., organ transplant recipients requiring immunosuppressive therapy).
Subjects who need to receive glucocorticoid (prednisone > 10 mg/day or equivalent dose of other similar drugs) or other immunosuppressive therapy due to certain conditions within 14 days prior to study drug administration.
Major surgery, or radical radiation therapy, or palliative radiation therapy within the previous 14 days, or radiopharmaceuticals (strontium, samarium, etc.) within 56 days before starting study treatment.
Received systemic anti-tumor therapy, including immunotherapy, biological therapy (tumor vaccines, cytokines, or growth factors to control cancer), etc. 14 days before starting study treatment.
Trial population
Patients with advanced esophageal cell carcinoma who are ready to receive PD-1 monoclonal antibody therpy
Trial design
Case-only
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
peripheral blood immune cells and immune molecules
Including absolute count of lymphocyte subsets, T lymphocyte subsets, B lymphocyte subsets, NK cell subsets, regulatory T cells, MDSC, etc. and IL-6, IL-10, etc.
Imaging examination
Including X-rays, CT, PET-CT and MR
Sponsors and contacts
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