Efficacy and Safety of Bronchial Infusion Chemotherapy Combined With Drug-loaded Microsphere Embolization of EqualSpheres in the Treatment of Advanced Non-small Cell Lung Cancer
Sponsor study identifier
interventional
70
1 country
1
Study Start
December 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This is a prospective, single-arm, open-label study designed to evaluate the efficacy and safety of bronchial infusion chemotherapy（BAI） combined with drug-loaded microsphere embolization of EqualSpheres in advanced Non-small cell lung cancer (NSCLC). Progression-free survival (PFS) will be evaluated as the primary endpoint.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 7, 2023
Actual (reported)November 13, 2023
Actual (reported)December 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
PFS
PFS was defined as the time from recruitment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
up to 3 years
ORR
up to 3 years
Overall survival (OS)
up to 3 years
Procedure: BAI combine with DEB-BACE: bronchial infusion chemotherapy combined with drug-loaded microsphere embolization of EqualSpheres 1. First treatment. Only infusion chemotherapy (THP + Platinum + Letitrexed), THP 20 \~30mg/m2, Nedaplatin 40mg/m2, Letitrexed 3mg/m2. 2. Second treatment. After infusionchemotherapy, EqualSpheres microsphere used for embolization: EqualSpheres microspheres (400 μm) 1tube was loaded and adsorbed THP (40 \~ 60mg/m2). End point of embolization: stagnation of blood flow in tumor feeding artery.
1. First treatment. Only infusion chemotherapy (THP + Platinum + Letitrexed), THP 20 \~30mg/m2, Nedaplatin 40mg/m2, Letitrexed 3mg/m2. 2. Second treatment. After infusionchemotherapy, EqualSpheres microsphere used for embolization: EqualSpheres microspheres (400 μm) 1tube was loaded and adsorbed THP (40 \~ 60mg/m2). End point of embolization: stagnation of blood flow in tumor feeding artery.
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Gang Wu
Zhengzhou, Henan, China
First Submitted
November 7, 2023
First Posted
November 13, 2023
Study Start
December 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 1, 2024
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
November 13, 2023
Record last verified: 2023-11
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