Not yet recruiting NCT07649369
A Phase II Study to Evaluate JMKX000197 Injection Versus Cisplatin in the Treatment of Malignant Pleural Effusion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JMKX000197, Cisplatin.
- Who it may be relevant to
- Registry conditions: Malignant Pleural Effusions (Mpe). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Controlled, Double-Blind, Multi-center Phase II Study to Evaluate JMKX000197 Injection Versus Cisplatin in the Treatment of Malignant Pleural Effusion
Overview
This study aims to evaluate the efficacy and safety of intrapleural JMKX000197 compared with intrapleural cisplatin in patients with malignant pleural effusion.
Interventions
- Drug JMKX000197
Intrapleural administration - Drug Cisplatin
Intrapleural administration
Primary outcome measures
- 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]
Secondary outcome measures (3)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Cancer Hospital, Chinese Academy of Medical Sciences — Beijing
Identifiers
NCT: NCT07649369 · JMKX000197-MPE201