NCT07019220招募中2 期
COBRA - Chemoablation for Low Grade Bladder Cancer: A Single Arm, Prospective, Open-label, Investigator-initiated Phase 2 Study
Ekaterina Laukhtina1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2023年12月27日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Clinical complete response (cCR)
研究概览
简要总结
The goal of this single arm, prospective, open-label, investigator-initiated Phase 2 clinical trial is to evaluate the efficacy of intravesical chemoablation in patients with low grade bladder cancer.
详细描述
In this study, patients with histologically confirmed Ta low-grade bladder cancer will undergo chemoablation with gemcitabine (six weekly instillations). The study aims to evaluate the efficacy, safety, and tolerability of chemoablation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/female participants who are at least 18 years of age on the day of providing documented informed consent will be enrolled in this study
- •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
- •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 metastasis
- •Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment
- •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
排除标准
- •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 (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
- •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
- •Known positive human immunodeficiency virus (HIV) test.
- •Female patients who are pregnant/breastfeeding.
- •Female patients of childbearing potential not using adequate contraception.
研究组 & 干预措施
Patients with low-grade NMIBC
Experimental
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Clinical complete response (cCR)
时间窗: From the end of treatment (EOT) visit to the follow-up visits (1 and 3 months post-treatment).
cCR defined as negative urine cytology and absence of macroscopic tumor at the cystoscopic evaluation
次要结局
- Pathological complete response (pCR)(From the end of treatment visit (EOT) to the follow-up visits (1 and 3 months post-treatment).)
- Patient-reported Outcomes based on EORTC QLQ-NMIBC24(Will be measured weekly during treatment period, at the end of treatment visit and follow-up visits (1 and 3 months post-treatment).)
- Patient-reported Outcomes based on EORTC QLQ-C30(Will be measured weekly during treatment period, at the end of treatment visit and follow-up visits (1 and 3 months post-treatment).)
研究者
Ekaterina Laukhtina
Dr.
Medical University of Vienna
研究点 (1)
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