Analysis of the Microenvironment of Lung Cancer and Exploration of the Mechanism of Resistance to Immunotherapy

NCT05636605 | Recruiting

• 1 other identifier: K2022179
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (3)

• objective response rate

  Refers to the proportion of patients whose tumor shrinkage reaches a certain amount and remains for a certain period of time, including CR + PR cases

  three years

• Major Pathologic Response

  \<10% viable tumor in resected lung and lymph nodes

  three-four months

• progression-free survival

  Patients with oncological diseases have a period of time from the start of treatment to the observation of disease progression or death due to any cause

  three years

Interventions

Multiomics analysis DIAGNOSTIC_TEST

Genome, proteomics, single cell RNA sequencing, and space transcriptome sequencing，etc

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Newly diagnosed lung cancer patients

You may qualify if:

• Histopathology or hemology diagnostics of lung cancer
• Patients have never received any antineoplastic therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator

Study Sites (1)

The Fourth Affiliated Hospital of Zhejiang University

Yiwu, Zhejiang, 310000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

tumor tissue, paracancerous tissue, blood, and lymphonodus

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kai Wang, PhD

  The Fourth Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kai Wang, PhD

CONTACT

13957158572; doctorhuxi@163.com

Jiangnan Zhao, PhD

CONTACT

18267098035; zjn911016@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2022
• First Posted: December 5, 2022
• Study Start: January 1, 2018
• Primary Completion: December 31, 2023
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 20, 2022

Record last verified: 2022-12

Locations

CN (1)