Clinical trial NCT05789498: Investigating the Biomarkers in Tumor and Peripheral Blood to Evaluate the Efficacy of Cancer Immunotherapy in Chest Cancer Patients
Official title: Investigating the Biomarkers in Tumor Microenvironment and Peripheral Blood Microenvironment to Evaluate the Efficacy of Cancer Immunotherapy in Chest Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Esophageal Cancer
Keywords: Cancer immunotherapy
Peripheral Blood
PBMC
T cells
Tumor antigen specific T cells
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2023-03-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a pathological diagnosis of lung cancer or esophageal cancer who have agreed to receive PD-1/PD-L1 antibody immunotherapy

Brief 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.

Eligibility 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.

Primary outcomes:
measure: The changes of immune cell subsets in tumor microenvironment and peripheral blood in patients
timeFrame: Within one month of completing immunotherapy
Secondary outcomes:
measure: 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
timeFrame: Within one month of completing immunotherapy
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The first affiliated hospital of soochow university
state: Jiangsu
Study officials:
References: