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

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.

Timeline

Start

2026-04-24

Primary completion

2028-10-30

Completion

2028-10-30

Publications

• Background Guan 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.
• Background Li 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.
• Background Xu 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.
• Background Dong 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.
• Background Feller-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.
• Background Porcel JM, Cordovilla R, Tazi-Mezalek R, Barrios-Barreto D, Perez-Pallares J, Novais E Bastos H, Martinez-Tomas R, Flandes-Aldeyturriaga J, Cases-Viedma E, Recalde B, Botana-Rial M. Efficacy and Safety of Indwelling Catheter for Malignant Pleural Effusions Related to Timing of Cancer Therapy: A Systematic Review. Arch Bronconeumol. 2023 Sep;59(9):566-574. doi: 10.1016/j.arbres.2023.06.007. Epub 2023 Jun 23. English, Spanish.
• Background 北京肿瘤学会临床研究专委会，中国医院协会肿瘤医院分会，王书航，等。恶性胸腔积液干预性临床研究设计专家共识[J]. 中华肿瘤防治杂志, 2025,32(8): 455-461.
• Background Kumar A, Xu B, Srinivasan D, Potter AL, Raman V, Lanuti M, Yang CJ, Auchincloss HG. Long-Term Survival of American Joint Committee on Cancer 8th Edition Staging Descriptors for Clinical M1a Non-Small Cell Lung Cancer. Chest. 2024 Mar;165(3):725-737. doi: 10.1016/j.chest.2023.07.4220. Epub 2023 Aug 5.

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