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Recruiting Observational

Investigating the Biomarkers in Tumor and Peripheral Blood to Evaluate the Efficacy of Cancer Immunotherapy in Chest Cancer Patients

NCT06790797 · tracked via the Priya Life Science China tracker
Sponsor
Phase
Observational
Started
2023-02-12
Last updated
2025-01-24

Condition(s) studied

Lung CancerEsophageal Cancer

Investigational drug(s) / intervention(s)

In vitro stimulation of Pbmc with tumor antigen nanoparticles

In vitro stimulation of Pbmc with tumor antigen nanoparticles: PBMCs were isolated from peripheral blood of cancer patients, and PBMC are co-incubated with nanoparticles loading tumor antigens for specific time in vitro to detect T cells that are related with efficacy of cancer immunotherapy. The content of such T cells are studies the correlation with the efficacy of cancer immunotherapy and patient prognosis.

Study summary

This study aims to investigate the impact of immunotherapy on the immune status of tumor microenvironment and peripheral blood of chest cancer patients. To do so, the investigators plan to collect tumor tissue and peripheral blood samples before and after immunotherapy, and use single-cell RNA sequencing, Multiplex immunohistochemistry, and flow cytometry. The investigators will analyze changes in the proportion of cancer cell-specific T-cell subpopulations related to treatment response before and after therapy, and seek biological markers that can predict the efficacy of immunotherapy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Patients with a pathological diagnosis of lung cancer or esophageal cancer who have agreed to receive PD-1/PD-L1 antibody immunotherapy; * Age between 18 and 80 years old; * ECOG PS score of 0 or 1; * Adequate organ and bone marrow function; * Anticipated survival time of at least 12 weeks; * Willing and able to provide written informed consent. Exclusion Criteria: * Patients with hematogenic infectious diseases, such as HIV, hepatitis B or hepatitis C. * Patients with tumor emergencies that require immediate treatment. * Poor vascular conditions. * Abnormal coagulation function or receiving anticoagulant or thrombolytic therapy. * Patients with hematogenic infectious diseases, such as HBV. * Patients with psychiatric disorders or severe mental illnesses. * Patients who have difficulty communicating or are unable to be followed up for a long time. * Other situations that are not suitable for inclusion in the study.

Primary outcome measure(s)

  • The changes of immune cell subsets in tumor microenvironment and peripheral blood in patients — Within one month of completing immunotherapy
    tumor antigen specific T cells measured by flow cytometry or single cell sequencing are increased after immunotherapy Single-cell sequencing and Flow cytometry are applied to detect immune cell subtypes and tumor-specific T cells in the tumor microenvironment and peripheral blood of patients with tumors who had received immunotherapy. Flow cytometric antibody used in the study to label activated T cells include CD19, CD3, CD4, CD8, CD25, CD39, CD137, CD69, Foxp3, IFN gamma et al.

Trial sites (1)

FacilityCityRegionStatus
The first affiliated hospital of soochow university Suzhou Jiangsu Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06790797 on ClinicalTrials.gov ↗ ← All trials in China