COBRA - Chemoablation for Low Grade Bladder Cancer: A single arm, prospective, open-label, investigator-initiated Phase 2 study

Medical University of Vienna0 个研究点目标入组 47 人开始时间: 2023年9月25日最近更新: 2024年2月26日

适应症

试验速览

暂无简介。

•- Diagnosis of a recurrent tumor and a history of TaLG BCa or diagnosis of primary TaLG BCa histologically confirmed by cold cup biopsy at screening or within 8 weeks before
•- On screening cystoscopy: Diameter of the largest lesion =15mm
•Number of lesions =5
•Version 1.1; 04.12.2022
•- Cystoscopy with bladder diagram including number, site, size and appearance of the tumors with photo documentation
•- Patient who has recurrence of and not other than TaLG NMIBC (low or intermediate EAU risk)
•- NMIBC requiring treatment with transurethral resection of bladder tumors (TURBT)
•- Negative voiding cytology for high grade (HG) disease within 8 weeks before Screening
•- No lymph node metastasis or distant metastasis
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 27

•- Tumors that clinicians suspect to be HG
•- Positive HG cytology according to Paris criteria
•- Diameter of tumor >15 mm
•- Number of lesions >5
•- Any previous intravesical therapy within 1 year
•- Previous HG NMIBC
•- Past or current muscle invasive bladder cancer (ie, T2, T3, T4) or metastatic UC
•- History of upper tract urothelial carcinoma (UTUC)
•- Clinically significant urethral stricture that would preclude passage of a urethral
•- History of neurogenic bladder; active urinary retention; any other condition that would
•prohibit normal voiding
•- Evidence of active urinary tract infection (UTI) that in the Investigator's opinion cannot
•be treated and resolved prior to biopsy and/or administration of study treatment
•- Patient refused to participate

发起方