CX3CR1+T Cell Predict Immunotherapy Efficacy

Active, not recruiting

• Conditions: Non-small Cell Lung Cancer

• Registration Number: NCT06054152
• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Brief 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.

Study Timeline

• Study Start: 2023-04-10
• Study First Submitted: 2023-09-19
• Study First Submitted QC: 2023-09-19
• Study First Posted: 2023-09-26
• Primary Completion: 2024-01-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-08
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
objective response rate（ORR）	4 weeks	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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, Shanghai, China

Hunan cancer hospital; 🇨🇳 Changsha, Hunan, China