A Phase II Study to Evaluate JMKX000197 Injection Versus Cisplatin in the Treatment of Malignant … (NCT07649369) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Phase II Study to Evaluate JMKX000197 Injection Versus Cisplatin in the Treatment of Malignant Pleural Effusion
China120 participantsStarted 2026-08-17
Plain-language summary
This study aims to evaluate the efficacy and safety of intrapleural JMKX000197 compared with intrapleural cisplatin in patients with malignant pleural effusion.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Puncture/drainage - Free Survival (PuFS)
Timeframe: 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