Investigating the Biomarkers in Tumor and Peripheral Blood to Evaluate the Efficacy of Cancer Immunotherapy in Chest Cancer Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorZhao Jun
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial population
Patients with a pathological diagnosis of lung cancer or esophageal cancer who have agreed to receive PD-1/PD-L1 antibody immunotherapy
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
In vitro stimulation of Pbmc with tumor antigen nanoparticles
Other interventionPBMCs 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
The changes of immune cell subsets in tumor microenvironment and peripheral blood in patients
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.
Time frame
Within one month of completing immunotherapySecondary outcomes
1
Exploring the feasibility of tumor-specific T cells as a biomarker for predicting the efficacy of immunotherapy: the absolute amount and proportion of tumor antigen specific T cells are increased in patients that response to cancer immunotherapy
Antigen-activated tumor-specific T cells (CD134, CD137, IL-10, IFN gamma et al. as markers) in the peripheral blood of patients with lung cancer and esophageal cancer are assessed by using flow cytometry, and immunotherapy response are assessed according to RECIST v1.1 criteria, and then the predictive power of tumor-specific T-cell numbers for immunotherapy response are about to be measured by using ROC curves and compared with PD-L1 expression; TMB and other predictive markers are about to be compared.
Time frame
Within one month of completing immunotherapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Zhao Jun
Lead sponsor
The First Affiliated Hospital of Soochow University
Sponsor institution
Source ClinicalTrials.gov