This study aims to evaluate the efficacy and safety of intrapleural JMKX000197 compared with intrapleural cisplatin in patients with malignant pleural effusion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Intrapleural administration
Intrapleural administration
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
Puncture/drainage - Free Survival (PuFS)
Time frame: From the date of chest tube removal after the last dose of treatment until the date of next puncture /drainage or date of death from any cause, whichever come first, up to approximately 24 months
Pleural effusion overall response (ORR)
Time frame: Up to approximately 24 months
Overall survival (OS)
Time frame: Up to approximately 24 months
AEs or SAEs
Time frame: Up to approximately 29 days
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