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New treatment option for Malignant Pleural Effusions (Mpe)
Official title First-in-Human Expanded Cohort Study of Intrapleural Administration of TolueneSulfonamide in Patients With Malignant Pleural Effusion
ClinicalTrials.gov ID: NCT07332858
What this study is testing
What is Intrapleural administration of TolueneSulfonamide?
Intrapleural administration of TolueneSulfonamide is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for malignant pleural effusions (mpe).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to evaluate the safety of intrapleural injection of TolueneSulfonamide in patients with malignant pleural effusion and to explore its potential effectiveness.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age between 18 and 75 years (inclusive) at the time of signing the informed consent form.
- Histologically or cytologically confirmed malignant pleural effusion, with the primary tumor diagnosed as non-small cell lung cancer (NSCLC).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, with an expected survival of at least 3 months.
- Presence of dyspnea symptoms.
- No prior local thoracic treatment within 1 month before enrollment, including intrapleural drug administration or thoracic radiotherapy (diagnostic...
You likely can't join if
- History of allergy or hypersensitivity to PTS or any of its excipients.
- Presence of uncontrolled intrapleural infection or severe loculated pleural effusion that is difficult to manage.
- Participation in another treatment clinical study within 3 months prior to enrollment (diagnostic studies are excluded).
- Severe organ dysfunction, including but not limited to coagulation disorders, congestive heart failure, malignant arrhythmias, coronary artery...
- Presence of uncontrolled infectious wounds.
- Pregnant or breastfeeding women.
See the full eligibility criteria
- Age between 18 and 75 years (inclusive) at the time of signing the informed consent form.
- Histologically or cytologically confirmed malignant pleural effusion, with the primary tumor diagnosed as non-small cell lung cancer (NSCLC).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, with an expected survival of at least 3 months.
- Presence of dyspnea symptoms.
- No prior local thoracic treatment within 1 month before enrollment, including intrapleural drug administration or thoracic radiotherapy (diagnostic thoracentesis is permitted).
- Except for the subject's current stable systemic anti-tumor therapy, any other ongoing tumor-related treatments must be suspended or discontinued after evaluation by the investigator to ensure they do not interfere with...
- Fully understands the study objectives and procedures, agrees to participate in the study, and provides written informed consent.
- History of allergy or hypersensitivity to PTS or any of its excipients.
- Presence of uncontrolled intrapleural infection or severe loculated pleural effusion that is difficult to manage.
- Participation in another treatment clinical study within 3 months prior to enrollment (diagnostic studies are excluded).
- Severe organ dysfunction, including but not limited to coagulation disorders, congestive heart failure, malignant arrhythmias, coronary artery disease requiring long-term medication, valvular heart disease, myocardial...
- Presence of uncontrolled infectious wounds.
- Pregnant or breastfeeding women.
- Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study.
- Criteria for withdrawal from the study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.