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Trial Title:
Investigating the Biomarkers in Tumor and Peripheral Blood to Evaluate the Efficacy of Cancer Immunotherapy in Chest Cancer Patients
NCT ID:
NCT05789498
Condition:
Lung Cancer
Esophageal Cancer
Conditions: Keywords:
Cancer immunotherapy
Peripheral Blood
PBMC
T cells
Tumor antigen specific T cells
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
In vitro stimulation of Pbmc with tumor antigen nanoparticles
Description:
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.
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.
Detailed description:
The potential biomarkers, that can be utilized to predict the efficacy of cancer
immunotherapy, in tumor tissue and peripheral blood are planning to be verified in lung
cancer patients and esophageal cancer patients. Tumor tissues, acquired from surgery to
remove tumor, are investigated by single-cell RNA sequencing, Multiplex
immunohistochemistry etc. to explore the biomarkers. In addition, immune microenvironment
of the peripheral blood mononuclear cells were analyzed by flow cytometry and ELISPOT to
quantify specific T cells groups that are correlated with efficacy of cancer
immunotherapy. The changes in the proportion of specific T-cell subpopulations that can
kill cancer cells will be analyzed before treatment and after treatment. The
immunotherapy responses before and after therapy are planning to analyzed with the
content of specific T cells. Thus the investigators will seek biological markers that can
predict the efficacy of immunotherapy.
Criteria for eligibility:
Study pop:
Patients with a pathological diagnosis of lung cancer or esophageal cancer who have
agreed to receive PD-1/PD-L1 antibody immunotherapy
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The first affiliated hospital of soochow university
Address:
City:
Suzhou
Zip:
215000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Zhao
Phone:
86-0512-67972216
Email:
zhaojia0327@126.com
Start date:
February 12, 2023
Completion date:
June 30, 2024
Lead sponsor:
Agency:
Zhao Jun
Agency class:
Other
Source:
The First Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05789498
