Skip to main content
OpenTrials
Completed

NCT Number: NCT06054152

CX3CR1+T Cell Predict Immunotherapy Efficacy

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hunan cancer hospital, Changsha, Hunan, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PD-1 inhibitor based immunotherapy

Drug

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.

Primary outcomes

  1. objective response rate(ORR)

    Time frame: 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 outcomes

  1. progression-free survival (PFS)

    Time frame: 1 year

    progression-free survival (PFS) defined as time from surgery until disease progression or death from any cause

  2. overall survival (OS)

    Time frame: 1 year

    Overall survival (OS) was defined as the time from surgery until death from any cause

Sponsors and collaborators

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 26, 2023
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.