Guidance of Adjuvant Instillation in Intermediate Risk Non-muscle Invasive Bladder Cancer by Drug Screens in Patient Derived Organoids. A Single Center, Open-label, Phase II Trial With a Feasibility Endpoint. (GAIN-INST-TRIAL)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Proportion of patients with successful drug selection
研究概览
简要总结
From patients with intermediate risk non-muscle invasive bladder cancer tumor (NMIBC) specimens will be harvested during transurethral resection. Fresh specimens will be cultured as patient derived organoids (PDO). After approx. 10 days, PDO are exposed to different drugs that are used as intravesical instillation agents in these patients (epirubicin, mitomycin, gemcitabine, docetaxel). After 2 days of exposure, PDO viability will be measured. The drug with the highest antitumor effect on PDO will be applied as weekly intravesical instillations 6 times. Thereafter, patients are followed according to the standard of care.
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
- •Age ≥ 18 years
- •Signed Informed Consent Form
- •ECOG performance status of 0 or 1
- •Histologically confirmed intermediate risk non muscle-invasive urothelial carcinoma of the bladder (pTa low grade) Patients
- •Representative fresh tumor specimen for PDO generation and drug screen
排除标准
- •Known previous high grade and/or high risk non muscle-invasive bladder cancer
- •Previous Intravesical biological/immuno (BCG) therapy
- •Pregnancy or nursing
- •Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol
- •Severe infection within 4 weeks prior to cycle 1, day 1
- •Contraindication for frequent catheterization
- •Voiding dysfunction
- •Pregnancy or nursing
- •Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 6 months after the last treatment.
- •Male subject who is unwilling to use acceptable method of effective contraception during IP treatment and through 6 months after the last dose of IP.
研究组 & 干预措施
Mitomycin
Patients in that PDOs show highest response to this drug in-vitro will be treated with Mitomycin.
干预措施: Mitomycin (Drug)
Gemcitabine
Patients in that PDOs show highest response to this drug in-vitro will be treated with Gemcitabine.
干预措施: Gemcitabine (Drug)
Docetaxel
Patients in that PDOs show highest response to this drug in-vitro will be treated with Docetaxel.
干预措施: Docetaxel (Drug)
Epirubicin
Patients in that PDOs show highest response to this drug in-vitro will be treated with Epirubicin.
If no significant drug selection can be performed in-vitro, Epirubicin will be the default for instillation.
干预措施: Epirubicin (Drug)
结局指标
主要结局
Proportion of patients with successful drug selection
时间窗: 24 months
Proportion of patients for which a specific selection of chemotherapeutic agent for intravesical instillation can be determined by using drug screens in PDOs.
次要结局
- Proportion of patients for whom patient-derived organoids (PDOs) can be successfully generated (regardless of subsequent drug screen)(24 months)
- Recurrence free survival 24 months after TURBT(24 months)
- Rate of recurrence in the study population(24 months)
- Progression free survival 24 months after TURBT(24 months)
- General quality of Life(24 months)
- Quality of Life related to the bladder cancer(24 months)
- Safety profile of instillations(24 months)
研究者
Roland Seiler-Blarer
Chairman
Hospital Centre Biel/Bienne