NCT05854030

Serum Exosomal miRNA Predicting the Therapeutic Efficiency in Lung Squamous Carcinoma

A Study on Serum Exosomal miRNA Predicting the Effective and Prognosis of Immunotherapy Combined With Chemotherapy in Pulmonary Squamous Carcinoma

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is an observational prospective bi-center study of 50 patients operated on advanced squamous cell carcinoma. The main aim is to investigate the efficacy of serum exosomal miRNA as a biomarker for predicting the therapeutic effect of immunotherapy combined with chemotherapy.

Detailed description

PD-L1 Testing in guiding patient selection for PD-1/PD-L1 inhibitor therapy in Lung Cancer exhibits insufficient sensitivity and efficacy. The investigators aimed to identify specific serum exosomal miRNA biomarkers that are highly sensitive and stable for predicting the therapeutic effect of immunotherapy combined with chemotherapy. So that the clinicians could use the biomarker to better stratify patients and select potential immunotherapy-beneficial subgroups before clinical decisions. We plan to enroll 50 patients with advanced treatment-naïve squamous cell carcinoma and 10 healthy people in the present study. Peripheral blood from the plasma of 10 healthy individuals and 50 pulmonary squamous cell carcinoma (SCC) patients will be collected before first-line treatment and after 2 cycles of anti-PD-L1 immunotherapy combined with chemotherapy. Firstly, exosomal miRNAs extracted from peripheral blood will be analyzed through high-throughput RNA sequencing to identify specific exosomal miRNAs. Secondly, through analyzing the PFS and OS follow-up data of patients, they are divided into different subgroups. We explore the value of early predicting efficacy of exosome miRNA basing on sequencing results. Thirdly, we compared the exo-miRNA biomarker with the value of PD-L1 expression in predicting the efficacy of immunotherapy. Lastly, we suggest exo-miRNA combined with PD-L1 as a biomarker combination in predicting anti-PD-L1 immunotherapy efficacy to better select the potential benefit population suitable for immunotherapy.

Conditions

• Lung Neoplasm
• Squamous Cell Carcinoma
• Exosomes

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	collect plasma samples and clinical features	8ml of peripheral blood need to be collected from pre- and post-treatment advanced pulmonary squamous carcinoma separately

Timeline

• Start date: 2022-04-01
• Primary completion: 2023-07-31
• Completion: 2023-08-31
• First posted: 2023-05-11
• Last updated: 2023-05-11

Locations

1 site across 1 country: China