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Clinical Trials in China / NCT07332858
Recruiting Phase 1/2

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

NCT07332858 · tracked via the Priya Life Science China tracker
Sponsor
Gang Hou
Phase
Phase 1/2
Started
2026-04-24
Last updated
2026-05-15

Condition(s) studied

Malignant Pleural Effusions (Mpe)Non Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Intrapleural administration of TolueneSulfonamideIntrapleural administration of normal saline injection

Intrapleural administration of TolueneSulfonamide: PTS 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: Normal 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.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age between 18 and 75 years (inclusive) at the time of signing the informed consent form. 2. Histologically or cytologically confirmed malignant pleural effusion, with the primary tumor diagnosed as non-small cell lung cancer (NSCLC). 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, with an expected survival of at least 3 months. 4. Presence of dyspnea symptoms. 5. No prior local thoracic treatment within 1 month before enrollment, including intrapleural drug administration or thoracic radiotherapy (diagnostic thoracentesis is permitted). 6. 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. 7. Fully understands the study objectives and procedures, agrees to participate in the study, and provides written informed consent. Exclusion Criteria: 1. History of allergy or hypersensitivity to PTS or any of its excipients. 2. Presence of uncontrolled intrapleural infection or severe loculated pleural effusion that is difficult to manage. 3. Participation in another interventional clinical study within 3 months prior to enrollment (diagnostic studies are excluded). 4. 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. 5. Presence of uncontrolled infectious wounds. 6. Pregnant or breastfeeding women. 7. Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study. 8. Criteria for withdrawal from the study.

Primary outcome measure(s)

  • Objective Response Rate — 4 weeks, 12 weeks, 6 months, and 12 months after treatment completion
    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).

Trial sites (1)

FacilityCityRegionStatus
China-Japan Friendship Hospital Beijing Beijing Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07332858 on ClinicalTrials.gov ↗ ← All trials in China