Malignant Pleural Effusions (Mpe)
Conditions
Brief summary
This study aims to evaluate the efficacy and safety of intrapleural JMKX000197 compared with intrapleural cisplatin in patients with malignant pleural effusion.
Interventions
DRUGJMKX000197
Intrapleural administration
DRUGCisplatin
Intrapleural administration
Sponsors
Shanghai Jeyou Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Participants with advanced solid tumors diagnosed by histopathology or cytopathology. * Moderate to large pleural effusions require intervention. * ECOG performance status: 0 to 2. * Life expectancy ≥ 3 months * Adequate organ function. * The serum pregnancy test of female participants of childbearing potential should be negative within 7 days prior to enrollment and must not be breastfeeding. With a fertile female/male must agree to use medically accepted non-pharmacological contraception during the study and for 6 months after the last dose.
Exclusion criteria
* Bilateral pleural effusion or concurrent peritoneal effusion, or concurrent pericardial effusion. * Pleural effusion is either encapsulated or severely separated; Or merge with chylothorax; Or combined with infectious pleural effusion. * Known allergies to the study drug or its excipient components. * Have participated in other clinical trials within 28 days prior to randomization. * Major surgery within 28 days prior to randomization. * Central nervous system metastatic disease, leptomeningeal disease, or cord compression. * Clinical unstable or uncontrolled concomitant cardiovascular, pulmonary, hepatic, renal or seizures diseases. * Active infections that require systemic treatment. * Have a history of organ transplantation. * Any further condition which, in the opinion of the Investigator, the participant is not suitable in the present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Puncture/drainage - Free Survival (PuFS) | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Pleural effusion overall response (ORR) | Up to approximately 24 months |
| Overall survival (OS) | Up to approximately 24 months |
| AEs or SAEs | Up to approximately 29 days |
Countries
China
Contacts
CONTACTYujia Song
PRINCIPAL_INVESTIGATORJie Wang
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed