jRCT2051230033招募中不适用
A clinical trial of HM-001 in patients with non-muscle invasive bladder cancer receiving TURBT therapy: Phase I/IIa, open-label, investigator-initiated study
未提供0 个研究点目标入组 48 人开始时间: 2023年9月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 主要终点
- Presence or absence of dose limiting toxicity (DLT)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Clinically diagnosed non-muscle invasive bladder cancer by cytology or cystoscopy.
- •TURBT is scheduled.
- •Any of the following, and none of the standard intravesical drug therapy after TURBT is judged to be an indication.
- •(1) Refractory or intolerant to intravesical instillation of at least one antineoplastic agent
- •(2) Refractory or intolerant to intravesical BCG therapy
- •(3) A first case but refusing intravesical instillation of antineoplastic agent
- •(4) A first case but refuses intravesical BCG therapy
- •Total cystectomy is not indicated.
- •Age 20 years or older at the time of informed consent.
- •Patients with ECOG PS 0, 1 or
- •Prognosis can be expected for more than 1 year.
- •Written informed consent has been obtained from the patient to be a subject of this study.
排除标准
- •Patients with non-muscle invasive bladder cancer (NMIBC) but with carcinoma in situ of the bladder (CIS).
- •Active multiple cancers (simultaneous multiple cancers and ectopic multiple cancers with disease-free interval within 5 years). However, carcinoma in situ or lesions equivalent to intramucosal carcinoma that are judged to be cured by local therapy are not included in active multiple cancers.
- •Requires continuous systemic administration (oral or intravenous) of steroids or immunosuppressants. However, topical treatments such as topical steroids and inhaled steroids are not covered.
- •Have a history of treatment with other investigational drugs or unapproved drugs within 28 days before obtaining informed consent.
- •Serious complications (severe congestive heart failure, renal failure, liver failure, uncontrolled diabetes, uncontrolled hypertension, etc.).
- •Active infection requiring systemic treatment.
- •Positive for any infectious disease screening (HIV, HBV, HCV*1, HTLV-1, syphilis).
- •1: Even if HCV antibody is positive, patients in whom HCV-RNA is not detected are not excluded.
- •Have a mental disorder that seems to affect the continuation of the study.
- •Abnormal values of renal function, liver function and bone marrow function at screening test as follows.
- •(1) White blood cell count: less than 3000/microliter
- •(2) Neutrophil count: less than 1500/microliter
- •(3) Hemoglobin: less than 10.0 g/dL
- •(4) Platelets: less than 100,000/microliter
- •(5) Total bilirubin: 1.5 mg/dL or more
- •(6) Either AST or ALT: 100 U/L or more
- •(7) eGFR: less than 30 mL/min/1.73m2
- •Difficulty in contraception from the start of study drug administration to the end of follow-up observation.
- •Pregnant women, women who are breast-feeding, who are determined to be pregnant based on an interview with a doctor. Even if the subject is breast-feeding, it is not excluded if breast-feeding can be interrupted from the start of study drug administration to the end of follow-up observation.
- •Patients who are judged to be unsuitable for the safe conduct of this study by investigators.
结局指标
主要结局
Presence or absence of dose limiting toxicity (DLT)
Presence or absence of dose limiting toxicity (DLT)
Bladder cancer non-recurrence rate up to last observation
时间窗: up to last observation
Bladder cancer non-recurrence rate up to last observation
次要结局
未报告次要终点
研究者
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