Immune Indicator Model for Predicting Efficacy of PD-1 Monoclonal Antibody

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorNanfang Hospital, Southern Medical University

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 2 trial groups
Group A: reactive group
Group B: non-reactive group

Trial outcomes

Primary outcomes

1

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.

Time frame
2022.1-2026.12
2

Imaging examination

Including X-rays, CT, PET-CT and MR

Time frame
2022.1-2026.12

Secondary outcomes

Other outcomes

Sponsors and contacts

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