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.
Parallel
Intrapleural administration of TolueneSulfonamide
DrugPTS Administration (One Treatment Cycle): One treatment cycle is defined as one week. PTS is administered three times per week on Days 1, 3, and 5. Prior to each administration, pleural effusion is drained as completely as possible until no further fluid can be obtained. The study drug is then administered via the indwelling drainage catheter, followed by an additional flush of 20 mL of normal saline. The drainage catheter is clamped for at least 24 hours after administration. After each injection, patients are instructed to maintain prone, lateral, and supine positions for approximately 30 minutes each to facilitate even distribution of the drug within the pleural cavity. During the same treatment cycle, the drainage catheter remains clamped until the next scheduled administration. After completion of treatment, catheter drainage and standard care are continued.
Intrapleural administration of normal saline injection
DrugNormal Saline Administration (One Treatment Cycle): One treatment cycle is defined as one week. Normal saline is administered three times per week on Days 1, 3, and 5. Prior to each administration, pleural effusion is drained as completely as possible until no further fluid can be obtained. Normal saline is then administered via the indwelling drainage catheter, followed by an additional flush of 20 mL of normal saline. The drainage catheter is clamped for at least 24 hours after administration. After each administration, patients are instructed to maintain prone, lateral, and supine positions for approximately 30 minutes each. During the same treatment cycle, the drainage catheter remains clamped until the next scheduled administration. After completion of treatment, catheter drainage and standard care are continued.
Objective Response Rate
Objective Response Rate (ORR) is defined as the proportion of patients achieving complete response (CR) or partial response (PR) among all enrolled patients, calculated as (CR + PR) / total number of patients × 100%, based on WHO criteria and assessed by imaging methods (ultrasound or computed tomography).
Percentage Change in Pleural Effusion Volume
The rate of change in pleural effusion volume is calculated as (baseline pleural effusion volume - post-treatment pleural effusion volume) / baseline pleural effusion volume, with pleural effusion volume assessed by ultrasound and computed tomography (CT)
Overall Survival (OS)
the time from enrollment to death from any cause
Incidence of Grade ≥3 treatment-emergent adverse events
Incidence of Grade ≥3 treatment-emergent adverse events
mMRC Dyspnea Score
Dyspnea will be assessed using the modified Medical Research Council (mMRC) Dyspnea Scale.
Click on the lead sponsor to view all of their trials.
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
