Hyperthermic Intravesical Perfusion for Muscle-invasive Bladder Urothelial Carcinoma
NCT ID: NCT05276167
Last Updated: 2022-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
40 participants
INTERVENTIONAL
2022-06-06
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Multidisciplinary Bladder-preservation Therapy for Bladder Cancer
NCT03756207
A Bladder-Sparing Treatment Strategies of Large-Volume Non-Muscle-Invasive Bladder Cancer
NCT06735287
Transurethral Resection of Bladder Tumor (TURBT) Combined With Adjuvant Intravenous GC Chemotherapy for Non-muscle-invasive Bladder Cancer
NCT02716961
TURBt With Adjuvant Cryoablation to Treat Bladder Cancer
NCT02760953
Adjuvant Intraarterial Chemotherapy Following Surgery to Treat Locally Advanced Bladder Cancer
NCT01627197
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
After follow-up, the effect of hyperthermic intravesical perfusion on the risk of intraoperative implantation of muscle-invasive bladder urothelial carcinoma and its safety will be evaluated.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
The experimental group
Participants in the experimental group will be treated with hyperthermic intravesical perfusion before receiving radical cystectomy.
hyperthermic intravesical perfusion
Participants in the experimental group will be treated with hyperthermic intravesical perfusion before receiving radical cystectomy
The control group
Participants in the control group will receive radical cystectomy alone.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
hyperthermic intravesical perfusion
Participants in the experimental group will be treated with hyperthermic intravesical perfusion before receiving radical cystectomy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 18-75 years of age on day of signing informed consent.
* Have histologically confirmed muscle invasive disease of the urinary bladder.
* Histology must be urothelial carcinoma (transitional cell carcinoma) or urothelial carcinoma with mixed histology/features.
* Clinical stage II-III and Have a surgical evaluation that documents the plan for multimodality therapy with a consolidative radical cystectomy.
* Eastern Cooperative Oncology Group 0-1 and good organ function.
Exclusion Criteria
* Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 28 days prior to study registration.
* Has a diagnosis of immunodeficiency or received systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study registration.
* Has a known additional malignancy that is progressing or required treatment ≤ 48 months of study registration. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer.
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Has an active autoimmune disease requiring systemic treatment.
* Has known evidence of interstitial lung disease or active, non-infectious pneumonitis.
* Has an active infection requiring systemic therapy.
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
* Has received prior therapy with an anti-programmed cell death 1, anti-programmed cell death-Ligand 1 antibody.
* Has a known history of Human Immunodeficiency Virus.
* Has known active Hepatitis B or Hepatitis C.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Henan Cancer Hospital
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
BR-PRG
Zhengzhou, Henan, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Ytj20210926
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.