2024-519288-17-00招募中2 期
Treatment of High-risk Non-muscle Invasive Bladder Cancer With IMUNO BGC Moreau RJ as Prophylaxis
Biofabri S.L., Fundacion Para La Investigacion En Urologia15 个研究点 分布在 1 个国家目标入组 306 人开始时间: 2024年12月11日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 306
- 试验地点
- 15
- 主要终点
- The effectiveness of the IMUNO BCG Moreau RJ strain will be assessed primarily by calculating the rate of progression at 24 months after the last transurethral resection (LTRU). The progression rate at 24 months is the proportion of patients who, after the last tumor resection and within a follow-up period of 24 months, undergo progression according to the TNM classification approved by the International Union Against Cancer in its 8th edition of 2017.
研究概览
简要总结
Assessment of progression-free survival in patients diagnosed with high-risk non-muscle infiltrating bladder tumours (NMIBT) treated with adjuvant IMUNO BCG Moreau RJ.
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
- •Signature of the informed consent before any activity related to the study, including the necessary evaluations for the selection
- •Age between 18 and 85 years at the time of signing the informed consent.
- •Urothelial tumor
- •High risk non-muscle invasive bladder tumor (defined as Ta-T1 and GIIb or GIII) diagnosed de novo or relapsed with or without associated in situ carcinoma. or carcinoma in situ isolated without visible tumor.
- •Patient with risk of recurrence or progression greater than or equal to 7 points, according to CUETO tables
排除标准
- •No muscle layer in pathological examination piece's
- •Woman considered potentially fertile. Following the Clinical Trial Facilitation Group (CTFG) recommendations, a woman is considered childbearing potential (WOCBP), following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
- •Patients with difficulties to perform the follow-up visits established in the protocol.
- •Non-urothelial tumor
- •Active cancer in any other location
- •Diagnosis of any other pathology that in the opinion of the researcher may increase the risk of the subject or reduce the chances of obtaining satisfactory data to achieve the objectives of the study, including the consumption of alcohol or any other drug.
- •Administration of BCG in the last year before signing the informed consent.
- •BCG first instillation contraindication during more than 15 days for any cause such as low bladder capacity, urinary infection, hematuria, etc
- •Impossibility of performing a second transurethral resection (ReRTU) between 4 and 8 weeks after the first.
- •Inability to start treatment within the first 4 weeks after the second transurethral resection (ReRTU)
- •Participation in another clinical study where they received a research drug in the 6 months prior to signing the informed consent
结局指标
主要结局
The effectiveness of the IMUNO BCG Moreau RJ strain will be assessed primarily by calculating the rate of progression at 24 months after the last transurethral resection (LTRU). The progression rate at 24 months is the proportion of patients who, after the last tumor resection and within a follow-up period of 24 months, undergo progression according to the TNM classification approved by the International Union Against Cancer in its 8th edition of 2017.
The effectiveness of the IMUNO BCG Moreau RJ strain will be assessed primarily by calculating the rate of progression at 24 months after the last transurethral resection (LTRU). The progression rate at 24 months is the proportion of patients who, after the last tumor resection and within a follow-up period of 24 months, undergo progression according to the TNM classification approved by the International Union Against Cancer in its 8th edition of 2017.
次要结局
- Progression rate at 12 months: proportion of patients, out of the total, who have been on treatment with the IMUNO BCG Moreau RJ strain and in whom the tumour has progressed within a 12-month follow-up period.
- Progression rate at 24 months: proportion of patients, out of the total, who have been on treatment with the IMUNO BCG Moreau RJ strain and in whom the tumour has progressed within a follow-up period of 24 months.
- Disease-free survival: tumour classification (TNM) from the date of first instillation (time zero) to recurrence or end of follow-up will be assessed.
- Quality of life: questionnaire published and validated in the scientific literature and adapted to Spanish, Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-BL) v. 4.
- Adverse reactions (ARs): the description of ARs will be based on the MedDRA dictionary of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The number and frequency of patients with AEs, their severity, as well as the distribution of all AEs will be described.
- Dropout rate due to toxicity: study withdrawals (number and percentage) due to the impossibility of continuing due to side effects will be evaluated, as well as those patients who have not discontinued.
- Immunological response: analysis of cytokines in urine prior to instillation at induction visits 1, 2, 5 and 6.
研究者
Ingrid Murillo Jelsbak
Scientific
Biofabri S.L.
研究点 (15)
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