CX3CR1+T Cell Predict Immunotherapy Efficacy

Prediction of Immunotherapy Efficacy Based on Transcriptome of CX3CR1+T Cell in Peripheral Blood

This study aimed to evaluate the correlation between the proportion of flow-sorted CX3CR1+T cells in peripheral blood and the CX3CR1+T-specific gene signature and the efficacy of immunotherapy.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: PD-1 inhibitor based immunotherapy

Detailed Description

The status and abundance of T cells vary across tumor microenvironments (TMEs) may fundamentally influence response to immunotherapy in non-small cell lung cancer. CX3CR1+ CD8+ T cells showed high migration in and were enriched in the blood, whose amplification is strongly associated with response to anti-PD-1 therapy and better survival. However, the prediction performance of CX3CR1+ T features and characteristics has not been fully validated. This study intends to conduct a clinical trial based on CX3CR1+ CD8+T Cell in peripheral blood to verify the association of proportion and specific transcriptome signature of CX3CR1+T Cell in immunotherapy efficacy prediction. With the help of RECIST 1.1 criteria, the investigators evaluate the clinical response after prescribed cycles of treatment to explore the correlation between peripheral blood markers and immunotherapy efficacy. To develop a low cost, robust and accurate prototype prediction model for NSCLC patients who take anti-PD-1 drugs is investigators final translational purpose.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China
      • Hunan Cancer Hospital
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai Pulmonary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with advanced non-small cell lung cancer (stage IIIA-IVB) anticipate to receive primary/first-line immunotherapy

Description

Inclusion Criteria:

1. At least 18 years old;
2. Diagnosed as Non-small cell lung cancer by biopsy before treatment;
3. Prepare to receive PD(L)1 inhibitor monotherapy or combined chemotherapy and antivascular drugs;
4. Lesion imaging can be measured and evaluated by RECIST1.1 standard;
5. Life expectancy exceeds 3 months;
6. ECOG score 0-2;
7. The newly IO treated patients did not receive immunotherapy, chemoradiotherapy before participate in the trial;
8. Sign informed consent and be willing to provide 5ml of peripheral blood for research

Exclusion Criteria:

1. Genetic test showed EGFR and ALK mutations;
2. Patients with other co-morbidities that may affect their follow-up and short-term survival;
3. Patients with any history of antitumor therapy;
4. Patients with a history of other systemic tumors;
5. The ineligible participants assessed by the researchers

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
objective response rate（ORR）	Imaging findings of CR, PR, and stable disease (SD) in all subjects evaluated according to RECIST V1.1 after completing 4 cycles of immunotherapy. best overall response (BoR) was evaluated in participants achieving complete and partial response.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression-free survival (PFS)	progression-free survival (PFS) defined as time from surgery until disease progression or death from any cause	1 year
overall survival (OS)	Overall survival (OS) was defined as the time from surgery until death from any cause	1 year

Collaborators and Investigators

• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
• Investigators: Principal Investigator: Chang Chen, MD, Ph.D., Shanghai Pulmonary Hospital, Shanghai, China; Principal Investigator: Deping Zhao, MD, Ph.D., Shanghai Pulmonary Hospital, Shanghai, China

Publications and helpful links

General Publications

• Zheng L, Qin S, Si W, Wang A, Xing B, Gao R, Ren X, Wang L, Wu X, Zhang J, Wu N, Zhang N, Zheng H, Ouyang H, Chen K, Bu Z, Hu X, Ji J, Zhang Z. Pan-cancer single-cell landscape of tumor-infiltrating T cells. Science. 2021 Dec 17;374(6574):abe6474. doi: 10.1126/science.abe6474. Epub 2021 Dec 17.
• Williams HN, Kelley J, Folineo D, Williams GC, Hawley CL, Sibiski J. Assessing microbial contamination in clean water dental units and compliance with disinfection protocol. J Am Dent Assoc. 1994 Sep;125(9):1205-11. doi: 10.14219/jada.archive.1994.0164.

Helpful Links

• Related Info
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Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2023
• Primary Completion (Actual): January 1, 2025
• Study Completion (Actual): June 20, 2025

Study Registration Dates

• First Submitted: September 19, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 26, 2023

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 19, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents, Immunological; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Immune Checkpoint Inhibitors
• Other Study ID Numbers: CTPI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No