Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
ID07332858

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

Led by Gang Hou · Updated on 2026-05-15

105

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

G

Gang Hou

Lead Sponsor

T

The Second Affiliated Hospital of Harbin Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the safety and possible effectiveness of intrapleural injection of TolueneSulfonamide (PTS) in patients with malignant pleural effusion (MPE), a condition often related to non-small cell lung cancer. This first-in-human study has two parts: an initial safety and dose-exploration phase, followed by a randomized controlled trial to evaluate the treatment's effectiveness. The study aims to better understand how PTS works in managing MPE and improving patient outcomes. In the first part, patients receive PTS through a catheter inserted in the pleural cavity, with treatments given three times a week for one week. Before each injection, fluid is drained from the pleural space, and after administration, patients change positions to help spread the drug evenly. In the second part, participants are randomly assigned to receive either PTS with catheter drainage or catheter drainage with a normal saline placebo, following the same treatment schedule. After treatment cycles, standard care and drainage continue. Participants will be closely monitored through clinical evaluations, symptom assessments, and imaging to measure changes in pleural effusion volume. Researchers will track the objective response rate at various time points up to 12 months after treatment. They will also assess survival, breathing difficulty scores, quality of life, and any significant side effects. The study duration includes treatment and follow-up periods lasting up to one year, allowing for thorough observation of treatment impact and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years (inclusive) at the time of signing the informed consent form
  • Histologically or cytologically confirmed malignant pleural effusion with primary tumor diagnosed as non-small cell lung cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 with expected survival of at least 3 months
  • Presence of dyspnea symptoms
  • No local thoracic treatment within 1 month before enrollment, except diagnostic thoracentesis
  • Ongoing tumor-related treatments other than current stable systemic anti-tumor therapy must be suspended or discontinued if they interfere with PTS treatment assessment
  • Understanding of study objectives and procedures with written informed consent provided
Not Eligible

You will not qualify if you...

  • History of allergy or hypersensitivity to PTS or its excipients
  • Uncontrolled intrapleural infection or severe loculated pleural effusion difficult to manage
  • Participation in another interventional clinical study within 3 months prior to enrollment (diagnostic studies excluded)
  • Severe organ dysfunction including coagulation disorders, 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
  • Presence of uncontrolled infectious wounds
  • Pregnant or breastfeeding women
  • Any condition judged by the investigator as unsuitable for study participation
  • Criteria for withdrawal from the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 week per treatment cycle

Participants receive intrapleural injections of either TolueneSulfonamide or normal saline via catheter drainage. One treatment cycle lasts one week, with three administrations on Days 1, 3, and 5. Before each administration, pleural effusion is drained, followed by drug or saline injection and catheter clamping for at least 24 hours. Participants maintain multiple positions after each injection to distribute the drug evenly. After treatment, catheter drainage and standard care continue.

3 visits per treatment cycle (in-person) on Days 1, 3, and 5

Follow-up

Duration - Up to 12 months

Participants are monitored for safety, response, and quality of life after treatment completion. Follow-up assessments occur up to 12 months to evaluate treatment effects and overall survival.

Visits at 4 weeks, 12 weeks, 6 months, and 12 months after treatment completion

Trial Site Locations

Total: 1 location

1

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China, 100029

Actively Recruiting

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Research Team

G

Gang Hou, PhD

L

Liwei Liao, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Effects of para-toluenesulfonamide intratumoral injection on non-small cell lung carcinoma with severe central airway obstruction: A multi-center, non-randomized, single-arm, open-label trial.

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Efficacy and Safety of Indwelling Catheter for Malignant Pleural Effusions Related to Timing of Cancer Therapy: A Systematic Review.

José M Porcel, Rosa Cordovilla, Rachid Tazi-Mezalek...

https://pubmed.ncbi.nlm.nih.gov/37429748

Long-Term Survival of American Joint Committee on Cancer 8th Edition Staging Descriptors for Clinical M1a Non-Small Cell Lung Cancer.

Arvind Kumar, Barry Xu, Deepti Srinivasan...

https://pubmed.ncbi.nlm.nih.gov/37544427