Bladder Cancer
Conditions
Interventions
Intravasical brachytherapy and BCG therapy:Intravasical brachytherapy and BCG therapy
Control group:Intravasical BCG therapy
Sponsors
Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Histologically confirmed diagnosis of high-risk NMIBC, with indications of TURBT; (2) Naive high risk NMIBC, without previous anti-tumor therapy; (3) The participant signed written informed consent for the trial; (4) Aged 18 to 75 years; (5) Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; (6) Estimated survival time > 1 year; (7) The participant agreed to provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion for biomarker evaluation; (8) Well preserved organ function.
Exclusion criteria
Exclusion criteria: (1) The patient has indications of radical cystecmy or radical radiotherapy; (2) Any clinical status, laboratory test or treatment that may interfere with the outcome of this trial; (3) Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial; (4) Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment; (5) Grave cardiovascular disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence free survival;PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;Incidence of complications; | — |
Countries
China
Contacts
Public ContactWang Huiqing
Department of Urology, Shanghai Changhai Hospital
Outcome results
None listed