Lung CancerNCT05789498
Investigating the Biomarkers in Tumor and Peripheral Blood to Evaluate the Efficacy of Cancer Immunotherapy in Chest Cancer Patients
An observational study of Lung Cancer and Esophageal Cancer, run by Zhao Jun at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer, Esophageal Cancer
- What is being tested?
- In vitro stimulation of Pbmc with tumor antigen nanoparticles
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 12 Feb 2023to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a pathological diagnosis of lung cancer or esophageal cancer who have agreed to receive PD-1/PD-L1 antibody immunotherapy
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of soochow university
Suzhou, Jiangsu, 215000
Jun Zhao, 86-0512-67972216, zhaojia0327@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer, Esophageal Cancer
- Being tested
- In vitro stimulation of Pbmc with tumor antigen nanoparticles
- Keywords
- Cancer immunotherapy, Peripheral Blood, PBMC, T cells, Tumor antigen specific T cells
- Medical subject headings
- Lung Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In vitro stimulation of Pbmc with tumor antigen nanoparticlesOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within one month of completing immunotherapy
Secondary outcomes (1)
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 (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.
Measured: Within one month of completing immunotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start12 Feb 2023
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhao Jun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhao Jun, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05789498
- Sponsor's protocol ID
- 20230212
- Status last verified
- Mar 2023
- First submitted
- 21 Feb 2023
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zeng W, Wang J, Chen Z, Yang J, Zhu A, Zheng Y, Chen X, Liu Y, Wu L, Xie Y, Ju S, Chen J, Ding C, Li C, Tong X, Liu M, Zhao J. Efficient Predictor for Immunotherapy Efficacy: Detecting Pan-Clones Effector Tumor Antigen-Specific T Cells in Blood by Nanoparticles Loading Whole Tumor Antigens. Adv Sci (Weinh). 2025 Jan;12(2):e2409913. doi: 10.1002/advs.202409913. Epub 2024 Nov 5.
PubMed 39498880
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Biomarkers in Tumor Microenvironment and Peripheral Blood Microenvironment to Evaluate the Efficacy of Cancer Immunotherapy in Chest Cancer Patients
- ClinicalTrials.gov ID
- NCT05789498
- Acronym / sponsor ID
- 20230212
- Conditions
- Lung Cancer, Esophageal Cancer
- Keywords
- Cancer immunotherapy, Peripheral Blood, PBMC, T cells, Tumor antigen specific T cells
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhao JunUniversity, hospital or other
- Study start
- 12 Feb 2023 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 29 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a pathological diagnosis of lung cancer or esophageal cancer who have agreed to receive PD-1/PD-L1 antibody immunotherapy
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In vitro stimulation of Pbmc with tumor antigen nanoparticlesPBMCs 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. | Other | – |
Primary outcome
The changes of immune cell subsets in tumor microenvironment and peripheral blood in patients
Time frame: 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.
1 secondary outcome
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
Time frame: Within one month of completing immunotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Derived from this study: PubMed 39498880Zeng W, Wang J, Chen Z, Yang J, Zhu A, Zheng Y, Chen X, Liu Y, Wu L, Xie Y, Ju S, Chen J, Ding C, Li C, Tong X, Liu M, Zhao J. Efficient Predictor for Immunotherapy Efficacy: Detecting Pan-Clones Effector Tumor Antigen-Specific T Cells in Blood by Nanoparticles Loading Whole Tumor Antigens. Adv Sci (Weinh). 2025 Jan;12(2):e2409913. doi: 10.1002/advs.202409913. Epub 2024 Nov 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Esophageal Cancer, run by Zhao Jun at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mi Liu (86-0512-67972216, mi.liu831116@icoud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of immune cell subsets in tumor microenvironment and peripheral blood in patients (time frame: Within one month of completing immunotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05789498, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.