This study aims to evaluate the safety of intrapleural injection of TolueneSulfonamide in patients with malignant pleural effusion and to explore its potential effectiveness.
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.
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.
Gang Hou
Lead sponsor
China-Japan Friendship Hospital
Sponsor institution
The Second Affiliated Hospital of Harbin Medical University
Collaborator
The Affiliated Hospital of Xuzhou Medical University
Collaborator
Anhui Chest Hospital
Collaborator