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

NCT ID: NCT06790797

Last Updated: 2025-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-12

Study Completion Date

2027-07-30

Brief Summary

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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

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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.

Conditions

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Lung Cancer Esophageal Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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In vitro stimulation of Pbmc with tumor antigen nanoparticles

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhao Jun

OTHER

Sponsor Role lead

Responsible Party

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Zhao Jun

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The first affiliated hospital of soochow university

Suzhou, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Mi Liu

Role: CONTACT

86-0512-67972216

Jun Zhao

Role: CONTACT

86-0512-67972216

Facility Contacts

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Jun Zhao

Role: primary

86-0512-67972216

Other Identifiers

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2024727

Identifier Type: -

Identifier Source: org_study_id

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