Using heated chemotherapy to prevent cancer spread during bladder surgery
The Effect of Hyperthermic Intravesical Perfusion on the Risk of Intraoperative Implantation of Muscle-invasive Bladder Urothelial Carcinoma and Its Safety Analysis
This study is testing whether using heated chemotherapy before bladder surgery can help prevent cancer from spreading in patients with muscle-invasive bladder cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Henan Cancer Hospital Government |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT05276167 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of hyperthermic intravesical perfusion on patients with muscle-invasive bladder urothelial carcinoma. Participants will be divided into two groups: one receiving the hyperthermic treatment before undergoing radical cystectomy, and the other receiving only the surgery. The study aims to assess the safety and effectiveness of this treatment in reducing the risk of cancer spreading during the surgical procedure. Follow-up evaluations will determine the outcomes related to intraoperative implantation and overall safety.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with histologically confirmed muscle-invasive bladder urothelial carcinoma who are scheduled for radical cystectomy.
Not a fit: Patients who are not surgical candidates or those receiving non-surgical treatment approaches will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of cancer spread during bladder surgery, improving patient outcomes.
How similar studies have performed: While similar approaches have been explored, this specific application of hyperthermic intravesical perfusion in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Zhengzhou, Henan
- Br-Prg — Zhengzhou, Henan, China (Recruiting)
Study contacts
- Study coordinator: Huaqi Yin
- Email: yhq901212@163.com
- Phone: +8613366621170
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.