First-in-Human Expanded Cohort Study of Intrapleural Administration of TolueneSulfonamide in Patients With Malignant Pleural Effusion

Recruiting now · Phase 1/Phase 2

Conditions studied: Malignant Pleural Effusions (Mpe), Non Small Cell Lung Cancer

In brief

This study aims to evaluate the safety of intrapleural injection of TolueneSulfonamide in patients with malignant pleural effusion and to explore its potential effectiveness.

Key facts

Study ID

NCT07332858

Run by

Gang Hou

People needed

105

Starts

2026-04-24

Expected to finish

2028-10-30

Last updated by the study team

2026-05-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 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 the assessment of PTS treatment.
• Fully understands the study objectives and procedures, agrees to participate in the study, and provides written informed consent.

You may not qualify 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 interventional 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 infarction, or refractory hypertension; severe cardiac, hepatic, or renal insufficiency, or active bleeding or thrombotic risk.
• 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.

Where it is running

• China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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