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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
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.
Gang Wu
Zhengzhou, Henan, China
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.
Time frame: up to 3 years
ORR
ORR is defined as the percentages of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria
Time frame: up to 3 years
Overall survival (OS)
The time from recruitment to death due to any cause.
Time frame: up to 3 years
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