NCT06142058

RecistTM Criteria in Evaluating the Efficacy of Targeted Therapy for NSCLC

Application of the RecistTM Criteria in Evaluating the Efficacy of Targeted Therapy for Advanced Non-small Cell Lung Cancer With Positive Driving Genes

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 44 (estimated)
• Sponsor: Xueqin Yang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Investigators established the efficacy evaluation criteria for tumor markers (RecistTM) in the preliminary research. Among patients with advanced non-small cell lung cancer, patients with positive driving genes are more likely to exhibit abnormalities in tumor markers, which suggests that this criteria may be more suitable for evaluating the efficacy of targeted therapy in driving gene positive patients. Moreover, The judgment rules of the prelimary criteria still need further improvement. Therefore, in order to broaden the application scope of the RecistTM criteria, further improve the evaluation rules of RecistTM criteria, and multi-dimensionally confirm the reliability of RecistTM criteria on efficacy evaluation, investigators plan to conduct research on the application of RecistTM criteria in evaluating the efficacy of targeted therapy for advanced non-small cell lung cancer with positive driving genes.

Detailed description

Investigators established the efficacy evaluation criteria for tumor markers (RecistTM) in the preliminary research. The establishment of this criteria makes the application of tumor markers in clinical efficacy evaluation more objective and solves the problem of consistency in clinical efficacy evaluation. Among patients with advanced non-small cell lung cancer, patients with positive driving genes are more likely to exhibit abnormalities in tumor markers, which suggests that this criteria may be more suitable for evaluating the efficacy of targeted therapy in driving gene positive patients. Moreover, The judgment rules of the preliminary criteria still need further improvement. . Therefore, in order to broaden the application scope of the RecistTM criteria, further improve the evaluation rules of RecistTM criteria, and multi-dimensionally confirm the reliability of RecistTM criteria on efficacy evaluation, investigators plan to conduct research on the application of RecistTM criteria in evaluating the efficacy of targeted therapy for advanced non-small cell lung cancer with positive driving genes. Investigators used statistical analysis to assess the consistency of efficacy evaluation between the RecistTM criteria and the RECIST criteria, the correlation between different efficacy and progression free survival (PFS) under the RecistTM, and the correlation between the efficacy of RecistTM criteria and ctDNA level.

Conditions

• Evaluation
• NSCLC
• Targeted Therapy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	RecistTM criteria	RecistTM criteria and RECIST criteria were used to evaluate the efficacy of targeted therapy for NSCLC with positive driving gene.

Timeline

• Start date: 2023-11-13
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2023-11-21
• Last updated: 2023-11-21

Locations

1 site across 1 country: China