Hyperthermic Intravesical Perfusion for Muscle-invasive Bladder Urothelial Carcinoma

NCT05276167 | Unknown DMC

• 1 other identifier: Ytj20210926
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

High-Risk, Non-Muscle Invasive Bladder Urothelial Carcinoma; Perfusion; Complications; Intraoperative Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time to disease progression

  3 years

Study Arms (2)

The experimental group

EXPERIMENTAL

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

Device: hyperthermic intravesical perfusion

The control group

NO INTERVENTION

Participants in the control group will receive radical cystectomy alone.

Interventions

hyperthermic intravesical perfusion DEVICE

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

The experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be willing and able to provide written informed consent for the trial.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

BR-PRG

Zhengzhou, Henan, 450008, China

RECRUITING

MeSH Terms

Conditions

Intraoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Huaqi Yin

CONTACT

+8613366621170; yhq901212@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will be randomly (1:1) divided into the experimental and control groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: March 11, 2022
• Study Start: June 6, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: September 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)