CX3CR1+T Cell Predict Immunotherapy Efficacy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: PD-1 inhibitor based immunotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years old; Diagnosed as Non-small cell lung cancer by biopsy before treatment; Prepare to receive PD(L)1 inhibitor monotherapy or combined chemotherapy and antivascular drugs; Lesion imaging can be measured and evaluated by RECIST1.1 standard; Life expectancy exceeds 3 months; ECOG score 0-2; The newly IO treated patients did not receive immunotherapy, chemoradiotherapy before participate in the trial; Sign informed consent and be willing to provide 5ml of peripheral blood for research Exclusion Criteria: Genetic test showed EGFR and ALK mutations; Patients with other co-morbidities that may affect their follow-up and short-term survival; Patients with any history of antitumor therapy; Patients with a history of other systemic tumors; The ineligible participants assessed by the researchers

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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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 |