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

ConditionMalignant Pleural Effusions (Mpe)
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • JMKX000197

    Drug

    Intrapleural administration

  • Cisplatin

    Drug

    Intrapleural administration

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Arm AExperimental treatment 1 intervention
Group B: Arm BExperimental treatment 1 intervention
Group C: Arm CActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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 outcomes

1

Pleural effusion overall response (ORR)

Time frame
Up to approximately 24 months
2

Overall survival (OS)

Time frame
Up to approximately 24 months
3

AEs or SAEs

Time frame
Up to approximately 29 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Jeyou Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: