CClinicalTrials.gg
Not yet recruitingNCT07649369Updated Jun 16, 2026

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

A Phase 2 interventional study of JMKX000197 and Cisplatin in Malignant Pleural Effusions (Mpe), sponsored by Shanghai Jeyou Pharmaceutical Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by Shanghai Jeyou Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Malignant Pleural Effusions (Mpe)
03

In context

Pleural Effusion, Malignant

154 studies on the registry are indexed under Pleural Effusion, Malignant; 39 are open to participants now.

This study's planned enrollment of 120 is above the median of 57 across 112 interventional studies indexed under Pleural Effusion, Malignant.

Browse Pleural Effusion, Malignant studies →

Lead sponsor

Shanghai Jeyou Pharmaceutical Co., Ltd. is the lead sponsor of 3 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Arm A

    JMKX000197

    Drug: JMKX000197

  • Experimental
    Arm B

    JMKX000197

    Drug: JMKX000197

  • Active comparator
    Arm C

    Cisplatin

    Drug: Cisplatin

Interventions

  • DrugJMKX000197

    Intrapleural administration

  • DrugCisplatin

    Intrapleural administration

06

What researchers measure

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

07

Study locations

1 site
  • Cancer Hospital, Chinese Academy of Medical Sciences
    Beijing, 100017, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07649369
Lead sponsor
Shanghai Jeyou Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jun 16, 2026
Start date
Aug 17, 2026 (estimated)
Primary completion
Jan 12, 2028 (estimated)
Completion
Aug 14, 2028 (estimated)
Last update
Jun 16, 2026

Study contacts

Yujia Song
Contact
songyujia@jeyoupharma.com
+8615640506016
Jie Wang
principal investigator · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion