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

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

Exclusion criteria

• 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.