NCT06790797

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
15mo left

Started Feb 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Feb 2023Jul 2027

Study Start

First participant enrolled

February 12, 2023

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 24, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2027

Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

4.5 years

First QC Date

January 18, 2025

Last Update Submit

January 18, 2025

Conditions

Lung CancerEsophageal Cancer

Keywords

Cancer immunotherapyPeripheral BloodPBMCT cellsTumor antigen specific T cells

Outcome Measures

Primary Outcomes (1)

  • 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 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

    Within one month of completing immunotherapy

Interventions

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first affiliated hospital of soochow university

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsEsophageal Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Central Study Contacts

Mi Liu

CONTACT

86-0512-67972216mi.liu831116@icoud.com

Jun Zhao

CONTACT

86-0512-67972216zhaojia0327@126.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 18, 2025

First Posted

January 24, 2025

Study Start

February 12, 2023

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

July 30, 2027

Last Updated

January 24, 2025

Record last verified: 2025-01

Locations

CN(1)