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This study aims to evaluate the efficacy and safety of intrapleural JMKX000197 compared with intrapleural cisplatin in patients with malignant pleural effusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | JMKX000197 |
|
| Arm B | Experimental | JMKX000197 |
|
| Arm C | Active Comparator | Cisplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JMKX000197 | Drug | Intrapleural administration |
| |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pleural effusion overall response (ORR) | Up to approximately 24 months | |
| Overall survival (OS) | Up to approximately 24 months | |
| AEs or SAEs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yujia Song | Contact | +8615640506016 | songyujia@jeyoupharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Jie Wang | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | 100017 | China |
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| ID | Term |
|---|---|
| D016066 | Pleural Effusion, Malignant |
| C565054 | Myeloproliferative Disorder, Chronic, with Eosinophilia |
| ID | Term |
|---|---|
| D010997 | Pleural Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Cisplatin |
| Drug |
Intrapleural administration |
|
| Up to approximately 29 days |
| D009369 |
| Neoplasms |
| D010996 | Pleural Effusion |
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |