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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Cancer; Lung Cancer
• Intervention / Treatment: Other: In vitro stimulation of Pbmc with tumor antigen nanoparticles

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Jun Zhao; Phone Number: 86-0512-67972216; Email: zhaojia0327@126.com
• Study Contact Backup: Name: Mi Liu; Phone Number: 86-0512-67972216; Email: mi.liu831116@icoud.com

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215000
      • Recruiting
      • the First Affiliated Hospital of Soochow University
      • Contact: Jun Zhao; Phone Number: 86-0512-67972216; Email: zhaojia0327@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within one month of completing immunotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within one month of completing immunotherapy

Collaborators and Investigators

• Sponsor: Zhao Jun

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2023
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027

Study Registration Dates

• First Submitted: January 18, 2025
• First Submitted That Met QC Criteria: January 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 18, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: T cells; PBMC; Cancer immunotherapy; Peripheral Blood; Tumor antigen specific T cells
• Other Study ID Numbers: 2024727

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No