- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05276167
Hyperthermic Intravesical Perfusion for Muscle-invasive Bladder Urothelial Carcinoma
The Effect of Hyperthermic Intravesical Perfusion on the Risk of Intraoperative Implantation of Muscle-invasive Bladder Urothelial Carcinoma and Its Safety Analysis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The participants will be divided into two groups (the experimental group and control group). Participants in the experimental group will be treated with hyperthermic intravesical perfusion before receiving radical cystectomy. Participants in the control group will receive radical cystectomy alone.
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Huaqi Yin
- Phone Number: +8613366621170
- Email: yhq901212@163.com
Study Locations
-
-
Henan
-
Zhengzhou, Henan, China, 450008
- Recruiting
- BR-PRG
-
Contact:
- Huaqi Yin, MD.
- Phone Number: +8613366621170
- Email: yhq901212@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Be willing and able to provide written informed consent for the trial.
- 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:
- A non-surgical approach recommended by the treating urologist due to any reason.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: The experimental group
Participants in the experimental group will be treated with hyperthermic intravesical perfusion before receiving radical cystectomy.
|
Participants in the experimental group will be treated with hyperthermic intravesical perfusion before receiving radical cystectomy
|
No Intervention: The control group
Participants in the control group will receive radical cystectomy alone.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of intraoperative tumor cell dissemination
Time Frame: 3 years
|
The rate of intraoperative tumor cell dissemination will be evaluated by lavage cytology of operating field
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to disease progression
Time Frame: 3 years
|
Disease progression was defined as recurrence or metastasis
|
3 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ytj20210926
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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