Multicenter, Randomized, Open-Label, Crossover Clinical Trial to Evaluate the Efficacy and Safety of Pentosan Polysulfate Sodium During Intravesical Bacillus Calmette-Guérin Instillation Therapy in Patients with Non-Muscle-Invasive Bladder Cancer

Asan Medical Center0 个研究点目标入组 192 人开始时间: 2026年8月26日最近更新: 2026年7月20日

适应症

试验速览

暂无简介。

•Adults aged 19 years or older (both male and female).
•Diagnosed with intermediate- or high-risk non-muscle-invasive bladder cancer (NMIBC) according to the WHO 2004/2022 classification (including Ta/T1 high-grade tumors or carcinoma in situ [CIS]), who are scheduled to undergo standard Bacillus Calmette-Guerin(BCG) induction therapy and the first maintenance therapy (typically at the 3-month time point, once weekly × 3 weeks) following a complete transurethral resection of bladder tumor (TURBT).
•Bacillus Calmette-Guerin(BCG)-naive patients.
•ECOG (Eastern Cooperative Oncology Group) performance status of 0 to
•Able to provide written informed consent prior to study participation, and capable of understanding and complying with the study procedures.
•Women of childbearing potential must have a negative pregnancy test and agree to use adequate contraception during the study period.

•Muscle-invasive bladder cancer (=T2), upper tract urothelial carcinoma (UTUC), distant metastasis, or cases requiring immediate radical cystectomy as a primary indication.
•Prior intravesical immunotherapy or chemotherapy, including Bacillus Calmette-Guerin, within the last 12 months.
•Active urinary tract infection (UTI), fever of 38°C or higher, gross hematuria, traumatic catheterization, or any other condition where the scheduled Bacillus Calmette-Guerin instillation is contraindicated under standard of care.
•Uncontrolled immunocompromised status, active tuberculosis, or a history of Bacillus Calmette-Guerin sepsis.
•Known history of hypersensitivity to pentosan polysulfate sodium (PPS), heparin-like drugs, or any excipients of the investigational product.
•Active hemorrhagic disease, clinically significant thrombocytopenia, a history of heparin-induced thrombocytopenia (HIT), or any high bleeding risk condition as determined by the investigator.
•Pre-existing severe retinal disease, suspected pigmentary maculopathy, or any condition that hinders adequate assessment of visual changes.
•Pregnant or lactating individuals.
•Any other condition where the investigator deems that the subject is unable to complete both treatment periods or transition successfully to the first maintenance therapy.

发起方