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Trial Title:
Analysis of the Microenvironment of Lung Cancer and Exploration of the Mechanism of Resistance to Immunotherapy
NCT ID:
NCT05636605
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Multiomics analysis
Description:
Genome, proteomics, single cell RNA sequencing, and space transcriptome sequencing，etc
Summary:
The investigators plan to conduct a multiomics analysis（such as, Genomics, proteomics,
single cell RNA sequencing, space transcriptomics）of tumor tissue and blood, aiming at
analyzing tumor heterogeneity, mapping the microenvironment map of lung cancer and
exploring the mechanism of sensitivity and resistance to anti-PD1/PD-L1 antibodies.
Detailed description:
Lung cancer is a highly heterogeneous disease. Cancer cells and cells within the tumor
microenvironment together determine disease progression, as well as response to or escape
from treatment. Tumor ecosystems are comprised of cancer cells, infiltrating immune
cells, stromal cells, and other cell types together with noncellular tissue components,
which interact and collectively determine disease progression as well as response to
therapy. It is well known that cancer patients elicit very individualized responses to
different treatments, demanding better characterization of the whole tumor ecosystem
beyond currently applied clinical typing of somatic mutations in cancer cells.
Immune checkpoint blockers (ICBs) have revolutionized the management of patients with
lung cancer. Blocking the interaction between the programmed cell death protein 1 (PD-1)
receptor and its primary ligand (PD-L1) has demonstrated remarkable anticancer activity,
and anti-PD-1/PD-L1 drugs have been approved both as single agents or in combination with
cytotoxic chemotherapy. However, most patients receiving anti-PD-1/PD-L1 monoclonal
antibodies do not derive benefit. Hence, there is a crucial need to identify reliable
predictive biomarkers of the response to anti-PD-1/PD-L1 agents to develop precision
medicine for NSCLC immunotherapy as well as to identify novel mechanisms underlying
resistance to ICBs.
To map the cell type-specific landscape of cancer cells and their tumor microenvironment
in lung cancer, the investigators plan to conduct a multiomics analysis（such as,
Genomics, proteomics, single cell RNA sequencing, space transcriptomics）of tumor tissue
and blood, aiming at analyzing tumor heterogeneity, mapping the microenvironment map of
lung cancer and exploring the mechanism of sensitivity and resistance to anti-PD1/PD-L1
antibodies.
Criteria for eligibility:
Study pop:
Newly diagnosed lung cancer patients
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Histopathology or hemology diagnostics of lung cancer
- Patients have never received any antineoplastic therapy
Exclusion Criteria:
- Within 5 years or at the same time, there are other active malignancies
- Currently participating in interventional clinical research treatment, or received
other research drugs or used research devices within 4 weeks before the first
administration
- Active autoimmune diseases requiring systemic treatment (such as the use of disease
relieving drugs, glucocorticoids or immunosuppressants) occurred within 2 years
before the first administration
- The study was receiving systemic glucocorticoid treatment (excluding local
glucocorticoids by nasal spray, inhalation or other means) or any other form of
immunosuppressive therapy within 7 days before the first administration; Note: It is
allowed to use glucocorticoid with physiological dose (prednisone ≤ 10mg/day or
equivalent)
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem
cell transplantation
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Fourth Affiliated Hospital of Zhejiang University
Address:
City:
Yiwu
Zip:
310000
Country:
China
Status:
Recruiting
Contact:
Last name:
Kai Wang, PhD
Phone:
13957158572
Email:
doctorhuxi@163.com
Contact backup:
Last name:
Jiangnan Zhao, PhD
Phone:
18267098035
Email:
zjn911016@126.com
Start date:
January 1, 2018
Completion date:
December 31, 2028
Lead sponsor:
Agency:
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Agency class:
Other
Collaborator:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Source:
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05636605
