First-in-Human Expanded Cohort Study of Intrapleural Administration of TolueneSulfonamide
This study aims to evaluate the safety of intrapleural injection of TolueneSulfonamide in patients with malignant pleural effusion and to explore its potential effectiveness.
| Condition(s) | Malignant Pleural Effusions (Mpe), Non Small Cell Lung Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 i |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Gang Hou |
| Locations | Beijing, Beijing Municipality, China |
| Start date | 2026-04-24 |
| NCT ID | NCT07332858 |
| Official listing | https://clinicaltrials.gov/study/NCT07332858 |