JPRN-jRCT2051230033招募中1 期
A clinical trial of HM-001 in patients with non-muscle invasive bladder cancer receiving TURBT therapy: Phase I/IIa, singlecenter, open-label, investigator-initiated study
Kawashima Atsunari0 个研究点目标入组 48 人开始时间: 2023年6月8日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Clinically diagnosed non-muscle invasive bladder cancer by cytology or cystoscopy.
- •2) TURBT is scheduled.
- •3) 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
- •4) Total cystectomy is not indicated.
- •5) Age 20 years or older at the time of informed consent.
- •6) Patients with ECOG PS 0, 1 or 2.
- •7) Prognosis can be expected for more than 1 year.
- •8) Written informed consent has been obtained from the patient to be a subject of this study.
排除标准
- •1) Patients with non-muscle invasive bladder cancer (NMIBC) but with carcinoma in situ of the bladder (CIS).
- •2) 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.
- •3) Requires continuous systemic administration (oral or intravenous) of steroids or immunosuppressants. However, topical treatments such as topical steroids and inhaled steroids are not covered.
- •4) Have a history of treatment with other investigational drugs or unapproved drugs within 28 days before obtaining informed consent.
- •5) Serious complications (severe congestive heart failure, renal failure, liver failure, uncontrolled diabetes, uncontrolled hypertension, etc.).
- •6) Active infection requiring systemic treatment.
- •7) Positive for any infectious disease screening (HIV, HBV, HCV*1, HTLV-1, syphilis, tuberculosis).
- •*1: Even if HCV antibody is positive, patients in whom HCV-RNA is not detected are not excluded.
- •8) Have a mental disorder that seems to affect the continuation of the study.
- •9) 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
- •10) Difficulty in contraception from the start of study drug administration to the end of follow-up observation.
- •11) 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.
- •12) Patients who are judged to be unsuitable for the safe conduct of this study by investigators.
研究者
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