HM-001-CT1 Study
- Conditions
- on-muscle invasive bladder cancer
- Registration Number
- JPRN-jRCT2051230033
- Lead Sponsor
- Kawashima Atsunari
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 48
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method