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

Prior treatment

• Bilateral pleural effusion or concurrent peritoneal effusion, or concurrent pericardial effusion.
• Have participated in other clinical trials within 28 days prior to randomization.
• Major surgery within 28 days prior to randomization.
• Clinical unstable or uncontrolled concomitant cardiovascular, pulmonary, hepatic, renal or seizures diseases.

Other illness

• Known allergies to the study drug or its excipient components.
• Central nervous system metastatic disease, leptomeningeal disease, or cord compression.
• 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.

Other

• Pleural effusion is either encapsulated or severely separated; Or merge with chylothorax; Or combined with infectious pleural effusion.

• 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.