NCT06054152

CX3CR1+T Cell Predict Immunotherapy Efficacy

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	PD-1 inhibitor based immunotherapy	Patients received at least 4 cycles of PD-1 inhibitor-based immune monotherapy or chemoimmunotherapy. PD-1 drug selection should be limited in 4 types of PD-1 inhibitor approved by China FDA and launched in China and Opdivo or Keytruda.

Timeline

• Start date: 2023-04-10
• Primary completion: 2025-01-01
• Completion: 2025-06-20
• First posted: 2023-09-26
• Last updated: 2025-06-25

Locations

2 sites across 1 country: China