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

Status: Recruiting

Location: See location...

Intervention Type: Drug

Study Type: Interventional

Study Phase: Phase 1/Phase 2

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

Participation Requirements

Sex: All

Minimum Age: 18

Maximum Age: 75

Healthy Volunteers: f

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• 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.

• No prior local thoracic treatment within 1 month before enrollment, including intrapleural drug administration or thoracic radiotherapy (diagnostic thoracentesis is permitted).

• 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.

• Fully understands the study objectives and procedures, agrees to participate in the study, and provides written informed consent.

Locations

Other Locations

China

China-Japan Friendship Hospital

RECRUITING

Beijing

Contact Information

Primary

Gang Hou, PhD

hougangcmu@163.com

＋86 13840065481

Backup

Liwei Liao, PhD

291633325@qq.com

＋86 18090027855

Time Frame

Start Date: 2026-04-24

Estimated Completion Date: 2028-10-30

Participants

Target number of participants: 105

Treatments

Experimental: Intrapleural PTS injection plus catheter drainage group

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.

Placebo_comparator: catheter drainage alone group

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.

Related Therapeutic Areas

Small Cell Lung Cancer (SCLC)

Lung Cancer

Pleural Effusion

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