2024-517106-28-00招募中2 期
COBRA - Chemoablation for Low Grade Bladder Cancer: A single arm, prospective, open-label, investigator-initiated Phase 2 study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Clinical complete response (cCR, absence of the macroscopic tumor after chemoablation)
研究概览
简要总结
To assess efficacy of intravesical gemcitabine in patients with TaLG bladder cancer
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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 screening
- •Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment. Female patients of childbearing potential must use adequate contraception during study period
- •Willing and able to provide informed consent
- •On screening cystoscopy: Diameter of the largest lesion ≤15mm
- •Number of lesions ≤5
- •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 metastasi
- •Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment
排除标准
- •Tumors that clinicians suspect to be HG
- •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
- •Positive human immunodeficiency virus (HIV) test
- •Female patients who are pregnant/breastfeeding
- •Female patients of childbearing potential not using adequate contraception
- •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 (within the last 3 years). It is allowed to include patients who had history of HG disease longer than 3 years ago
- •Past or current muscle invasive bladder cancer (i.e., T2, T3, T4) or metastatic UC
- •History of upper tract urothelial carcinoma (UTUC)
- •Clinically significant urethral stricture that would preclude passage of a urethral catheter
结局指标
主要结局
Clinical complete response (cCR, absence of the macroscopic tumor after chemoablation)
Clinical complete response (cCR, absence of the macroscopic tumor after chemoablation)
次要结局
- Pathological complete response (pCR)
- Overall response (cCR + pCR)
- Treatment-related adverse events evaluated using the National Cancer Institute’s Common Terminology Criteria for Adverse Events (version 5.0)
- Rate of treatment discontinuation (at least 5 from 6 instillations within 8 weeks)
- Health-related quality of life
研究者
Department of Urology
Scientific
Medical University Of Vienna
研究点 (1)
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