Tests TolueneSulfonamide injected into the chest in people with fluid from lung cancer

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with fluid around the lung caused by non-small cell lung cancer who feel short of breath. It tests a drug put into the chest cavity.

Age

18 to 75 years

Sex

All sexes can join.

Disease stage

Malignant pleural effusion (cancer fluid around the lung) confirmed by tissue or cell testing, with non-small cell lung cancer (NSCLC) as the original tumor. Performance status ECOG 0-2, expected survival of at least 3 months, and breathlessness (dyspnea).

Earlier treatment

No treatment applied directly in the chest within 1 month before joining, such as drugs into the pleural space or chest radiotherapy. A diagnostic fluid draw is allowed. Current stable cancer treatment through the body may continue; other cancer-related treatments must be paused or stopped.

Main reasons for not taking part

• Allergy to the study drug (PTS) or its ingredients
• Uncontrolled infection in the pleural space, or severe walled-off fluid that is hard to manage
• Took part in another interventional study within 3 months before joining
• Severe organ problems, such as heart, liver or kidney failure, bleeding disorders or active bleeding
• Pregnant or breastfeeding women

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 75 years old?YesNo

What the trial wants to find out

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

The 2 groups in the trial

• Intrapleural PTS injection plus catheter drainage groupTreatment being tested

  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.

  Treatment: Intrapleural administration of TolueneSulfonamide

• catheter drainage alone groupPlacebo, for comparison

  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.

  Treatment: Intrapleural administration of normal saline injection