Hyperthermic Intravesical Perfusion for Muscle-invasive Bladder Urothelial Carcinoma
Primary Purpose
High-Risk, Non-Muscle Invasive Bladder Urothelial Carcinoma, Perfusion; Complications, Intraoperative Complications
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
hyperthermic intravesical perfusion
Sponsored by
About this trial
This is an interventional treatment trial for High-Risk, Non-Muscle Invasive Bladder Urothelial Carcinoma
Eligibility Criteria
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.
Sites / Locations
- BR-PRGRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
The experimental group
The control group
Arm Description
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.
Outcomes
Primary Outcome Measures
Rate of intraoperative tumor cell dissemination
The rate of intraoperative tumor cell dissemination will be evaluated by lavage cytology of operating field
Secondary Outcome Measures
Time to disease progression
Disease progression was defined as recurrence or metastasis
Full Information
NCT ID
NCT05276167
First Posted
November 24, 2021
Last Updated
September 15, 2022
Sponsor
Henan Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05276167
Brief Title
Hyperthermic Intravesical Perfusion for Muscle-invasive Bladder Urothelial Carcinoma
Official Title
The Effect of Hyperthermic Intravesical Perfusion on the Risk of Intraoperative Implantation of Muscle-invasive Bladder Urothelial Carcinoma and Its Safety Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henan Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the effect of hyperthermic intravesical perfusion on the risk of intraoperative implantation of muscle-invasive bladder urothelial carcinoma and its safety.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High-Risk, Non-Muscle Invasive Bladder Urothelial Carcinoma, Perfusion; Complications, Intraoperative Complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model 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.
Masking
Participant
Masking Description
The participants will be randomly (1:1) divided into the experimental and control groups.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The experimental group
Arm Type
Experimental
Arm Description
Participants in the experimental group will be treated with hyperthermic intravesical perfusion before receiving radical cystectomy.
Arm Title
The control group
Arm Type
No Intervention
Arm Description
Participants in the control group will receive radical cystectomy alone.
Intervention Type
Device
Intervention Name(s)
hyperthermic intravesical perfusion
Intervention Description
Participants in the experimental group will be treated with hyperthermic intravesical perfusion before receiving radical cystectomy
Primary Outcome Measure Information:
Title
Rate of intraoperative tumor cell dissemination
Description
The rate of intraoperative tumor cell dissemination will be evaluated by lavage cytology of operating field
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Time to disease progression
Description
Disease progression was defined as recurrence or metastasis
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huaqi Yin
Phone
+8613366621170
Email
yhq901212@163.com
Facility Information:
Facility Name
BR-PRG
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huaqi Yin, MD.
Phone
+8613366621170
Email
yhq901212@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hyperthermic Intravesical Perfusion for Muscle-invasive Bladder Urothelial Carcinoma
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