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

Recruiting

• Conditions: Lung Cancer; Esophageal Cancer

• Registration Number: NCT05789498
• Lead Sponsor: Zhao Jun

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.

Study Timeline

• Study Start: 2023-02-12
• Study First Submitted: 2023-02-21
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-16
• Last Update Submitted: 2023-03-16
• Study First Posted: 2023-03-29
• Last Update Posted: 2023-03-29
• Primary Completion: 2024-03-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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	Within one month of completing immunotherapy	Antigen-activated tumor-specific T cells (CD39, CD137, CD69, 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.

Trial Locations

Locations (1)

The first affiliated hospital of soochow university; 🇨🇳 Suzhou, Jiangsu, China