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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Jeyou Pharmaceutical Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • JMKX000197
  • Cisplatin

Treatment groups

120 Participants
are divided into 3 treatment groups