Clinical trial NCT06054152: CX3CR1+T Cell Predict Immunotherapy Efficacy
Official title: Prediction of Immunotherapy Efficacy Based on Transcriptome of CX3CR1+T Cell in Peripheral Blood
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: objective response rate（ORR）
timeFrame: 4 weeks
Secondary outcomes:
measure: progression-free survival (PFS)
timeFrame: 1 year
measure: overall survival (OS)
timeFrame: 1 year
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan cancer hospital
state: Hunan
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Chang Chen, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Deping Zhao, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Yamauchi T, Hoki T, Oba T, Jain V, Chen H, Attwood K, Battaglia S, George S, Chatta G, Puzanov I, Morrison C, Odunsi K, Segal BH, Dy GK, Ernstoff MS, Ito F. T-cell CX3CR1 expression as a dynamic blood-based biomarker of response to immune checkpoint inhibitors. Nat Commun. 2021 Mar 3;12(1):1402. doi: 10.1038/s41467-021-21619-0.