Hyperthermic Intravesical Perfusion for Muscle-invasive Bladder Urothelial Carcinoma

Intraoperative Complications Clinical Trial

Official title:

The Effect of Hyperthermic Intravesical Perfusion on the Risk of Intraoperative Implantation of Muscle-invasive Bladder Urothelial Carcinoma and Its Safety Analysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05276167
• Other study ID #: Ytj20210926
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2022
• Est. completion date: December 2025

Study information

• Verified date: February 2022
• Source: Henan Cancer Hospital
• Contact: Huaqi Yin
• Phone: +8613366621170
• Email: yhq901212[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the effect of hyperthermic intravesical perfusion on the risk of intraoperative implantation of muscle-invasive bladder urothelial carcinoma and its safety.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Intraoperative Complications
• Perfusion; Complications

Intervention

Device:
• hyperthermic intravesical perfusion
Participants in the experimental group will be treated with hyperthermic intravesical perfusion before receiving radical cystectomy

Locations

Country	Name	City	State
China	BR-PRG	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of intraoperative tumor cell dissemination	The rate of intraoperative tumor cell dissemination will be evaluated by lavage cytology of operating field	3 years
Secondary	Time to disease progression	Disease progression was defined as recurrence or metastasis	3 years