Malignant Pleural Effusions (Mpe)Phase 2NCT07649369
A Phase II Study to Evaluate JMKX000197 Injection Versus Cisplatin in the Treatment of Malignant Pleural Effusion
A Phase 2 study testing JMKX000197 and Cisplatin in people with Malignant Pleural Effusions (Mpe), run by Shanghai Jeyou Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study aims to evaluate the efficacy and safety of intrapleural JMKX000197 compared with intrapleural cisplatin in patients with malignant pleural effusion. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Pleural Effusions (Mpe)
- What is being tested?
- JMKX000197 and Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 17 Aug 2026to 14 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, 100017
Jie Wang, +8613910704669, zlhuxi@163.com
About this study
Official title: 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.
- Conditions
- Malignant Pleural Effusions (Mpe)
- Being tested
- JMKX000197, Cisplatin
- Medical subject headings
- Pleural Effusion, Malignant, Myeloproliferative Disorder, Chronic, with Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMKX000197Drug
Intrapleural administration
CisplatinDrug
Intrapleural administration
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | JMKX000197 Receives: Drug: JMKX000197 |
| Arm B | Experimental | JMKX000197 Receives: Drug: JMKX000197 |
| Arm C | Active comparator | Cisplatin Receives: Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Puncture/drainage - Free Survival (PuFS)
Measured: 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 (3)
Pleural effusion overall response (ORR)
Measured: Up to approximately 24 months
Overall survival (OS)
Measured: Up to approximately 24 months
AEs or SAEs
Measured: Up to approximately 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start17 Aug 2026 (estimated)
- Primary completion12 Jan 2028 (estimated)
- Study completion14 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural Effusions (Mpe)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jeyou Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jie Wang, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649369
- Sponsor's protocol ID
- JMKX000197-MPE201
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Double-Blind, Multi-center Phase II Study to Evaluate JMKX000197 Injection Versus Cisplatin in the Treatment of Malignant Pleural Effusion
- ClinicalTrials.gov ID
- NCT07649369
- Acronym / sponsor ID
- JMKX000197-MPE201
- Conditions
- Malignant Pleural Effusions (Mpe)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai Jeyou Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2026 (estimated)
- Primary completion
- 12 Jan 2028 (estimated)
- Study completion
- 14 Aug 2028 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the efficacy and safety of intrapleural JMKX000197 compared with intrapleural cisplatin in patients with malignant pleural effusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: JMKX000197JMKX000197 |
| Arm B | Experimental | Drug: JMKX000197JMKX000197 |
| Arm C | Active comparator | Drug: CisplatinCisplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JMKX000197Intrapleural administration | Drug | Arm A, Arm B |
| CisplatinIntrapleural administration | Drug | Arm C |
Primary outcome
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
3 secondary outcomes
Pleural effusion overall response (ORR)
Time frame: Up to approximately 24 months
Overall survival (OS)
Time frame: Up to approximately 24 months
AEs or SAEs
Time frame: Up to approximately 29 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Malignant Pleural Effusions (Mpe)
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Union-LC-MPE Cohort:A Multicenter Cohort Study on Diagnosis and Prognosis of Malignant Pleural Effusion in Lung Cance
Malignant Pleural Effusions (Mpe), Lung Cancer (Diagnosis)
Active, not recruitingPhase 2
Intrapleural Catheter Daily Versus Three Times a Week Drainage
Advanced Cancer, Pleural Effusion
Recruiting
Safety and Feasibility of Medical Thoracoscopy Using Single-use Flexible Bronchoscope Versus SemiRigid Pleuroscope in Pleural Effusion
Malignant Pleural Effusions (Mpe), Medical Thoracoscopy
RecruitingEarly Phase 1
Alteplase Through an Indwelling Pleural Catheter for the Management of Symptomatic Septated Malignant Pleural Effusion
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Not yet recruitingPhase 2
Furmonertinib Plus Radiotherapy for EGFR+ NSCLC With Pleural Effusion
Lung Cancer (NSCLC), Malignant Pleural Effusions (Mpe)- Pleurodesis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jie Wang principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JMKX000197 and Cisplatin in people with Malignant Pleural Effusions (Mpe), run by Shanghai Jeyou Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yujia Song (+8615640506016, songyujia@jeyoupharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.