A Phase II Study to Evaluate JMKX000197 Injection Versus Cisplatin in the Treatment of Malignant Pleural Effusion

A Randomized, Controlled, Double-Blind, Multi-center Phase II Study to Evaluate JMKX000197 Injection Versus Cisplatin in the Treatment of Malignant Pleural Effusion

This study aims to evaluate the efficacy and safety of intrapleural JMKX000197 compared with intrapleural cisplatin in patients with malignant pleural effusion.

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.