NCT04996927

18F-FDG PET/CT to Evaluate pD-1 Monoclonal Antibody With First-line Chemotherapy in Advanced NSCLC

A Prospective, Single-arm, Observational Clinical Study Based on 18F-FDG PET/CT to Evaluate the True Efficacy and Immune Response of PD-1 Monoclonal Antibody Combined With First-line Chemotherapy in Advanced Non-small Cell Lung Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study is a diagnostic study. Subjects were enrolled from clinical stage IIIB or IV NSCLC patients who received standard first-line chemotherapy combined with PD-1 monoclonal antibody immunotherapy and received 18F-FDG PET/CT imaging before treatment, after 2 courses of treatment, and at the time of disease progression.At the same time, the blood routine, liver and kidney function, inflammatory indexes and other laboratory data of the subjects participating in the study were collected. Based on 18F-FDG PET Ipercist standard and comprehensive laboratory indicators, the subjects were evaluated for tumor biological characteristics prediction and clinical staging, PD-1 immune efficacy monitoring and evaluation, tumor recurrence monitoring and re-staging. At the same time, the systemic immune response and immune-related adverse events during the treatment process were evaluated in order to establish a better evaluation standard and system for the comprehensive evaluation of PD-1 immunotherapy.This study plans to set the sample size as 50 cases.

Detailed description

This is a diagnostic study. Subjects were enrolled from clinical stage IIIB or IV NSCLC patients who received standard first-line chemotherapy combined with PD-1 monoclonal antibody immunotherapy and underwent 18F-FDG PET/CT imaging before treatment, after two lines of treatment and at the time of disease progression, while routine blood counts, liver and kidney function, inflammatory indices and other laboratory data were collected from subjects enrolled in the study. Based on standard 18F-FDG PET Ipercist and comprehensive laboratory indicators, subjects were evaluated for prediction of tumour biological characteristics and clinical staging, monitoring and evaluation of PD-1 immune efficacy, monitoring of tumour recurrence and restaging. At the same time, the systemic immune response and immune-related adverse events during the treatment process were evaluated to establish a better evaluation standard and system for the comprehensive evaluation of PD-1 immunotherapy.

Conditions

• NSCLC

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2021-08-09
• Last updated: 2023-02-15

Locations

1 site across 1 country: China