Clinical trial · Interventional

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

NCT07332858CI-TRIAL-00111737recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Malignant Pleural Effusions (Mpe)	—	UNRESOLVED	—
Non Small Cell Lung Cancer	Lung Non-Small Cell Carcinoma	ALIAS	0.90

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Intrapleural administration of normal saline injection	Drug	—	UNRESOLVED
Intrapleural administration of TolueneSulfonamide	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Intrapleural PTS injection plus catheter drainage group
description
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.
interventionNames
1. Drug: Intrapleural administration of TolueneSulfonamide
type
PLACEBO_COMPARATOR
label
catheter drainage alone group
description
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 75 Years

Show eligibility criteria text

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.

References

Publications (8)

BACKGROUNDGuan WJ, Li SY, Zhong NS. Effects of para-toluenesulfonamide intratumoral injection on pulmonary adenoid cystic carcinoma complicating with severe central airway obstruction: a 5-year follow-up study. J Thorac Dis. 2018 Apr;10(4):2448-2455. doi: 10.21037/jtd.2018.03.70. PMID 29850151
BACKGROUNDLi SY, Li Q, Guan WJ, Huang J, Yang HP, Wu GM, Jin FG, Hu CP, Chen LA, Xu GL, Liu SZ, Wu CG, Han BH, Xiang Y, Zhao JP, Wang J, Zhou X, Li HP, Zhong NS. 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. Lung Cancer. 2016 Aug;98:43-50. doi: 10.1016/j.lungcan.2016.05.012. Epub 2016 May 17. PMID 27393505
BACKGROUNDXu YF, Chen YR, Bu FL, Huang YB, Sun YX, Li CY, Sellick J, Liu JP, Qin DM, Liu ZL. Chinese herbal injections versus intrapleural cisplatin for lung cancer patients with malignant pleural effusion: A Bayesian network meta-analysis of randomized controlled trials. Front Oncol. 2022 Sep 20;12:942941. doi: 10.3389/fonc.2022.942941. eCollection 2022. PMID 36203451
BACKGROUNDDong X, Huang Y, Yi T, Hu C, Gao Q, Chen Y, Zhang J, Chen J, Liu L, Meng R, Zhang S, Dai X, Fei S, Jin Y, Yin P, Hu Y, Wu G. Intrapleural infusion of tumor cell-derived microparticles packaging methotrexate or saline combined with pemetrexed-cisplatin chemotherapy for the treatment of malignant pleural effusion in advanced non-squamous non-small cell lung cancer: A double-blind, randomized, placebo-controlled study. Front Immunol. 2022 Oct 5;13:1002938. doi: 10.3389/fimmu.2022.1002938. eCollection 2022. PMID 36275698
BACKGROUNDFeller-Kopman DJ, Reddy CB, DeCamp MM, Diekemper RL, Gould MK, Henry T, Iyer NP, Lee YCG, Lewis SZ, Maskell NA, Rahman NM, Sterman DH, Wahidi MM, Balekian AA. Management of Malignant Pleural Effusions. An Official ATS/STS/STR Clinical Practice Guideline. Am J Respir Crit Care Med. 2018 Oct 1;198(7):839-849. doi: 10.1164/rccm.201807-1415ST. PMID 30272503

Registry

Dates and enrollment

Start: Apr 24, 2026
Primary completion: Oct 30, 2028
Completion: Oct 30, 2028
First posted: Jan 12, 2026
Last update posted: May 15, 2026
Enrollment: 105 (estimated)
Lead sponsor: Gang Hou OTHER
Collaborators: The Second Affiliated Hospital of Harbin Medical University; The Affiliated Hospital of Xuzhou Medical University; Anhui Chest Hospital
Keywords: Malignant Pleural Effusion, Para-toluenesulfonamide

Data updated 22 days agoSource updated May 15, 2026source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
China	1	1

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.