Actively Recruiting
Risk-stratification Based Bladder-sparing Modalities for Muscle-invasive Bladder Cancer
Led by Fudan University · Updated on 2024-07-12
30
Participants Needed
1
Research Sites
116 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Neoadjuvant chemotherapy plus radical cystectomy is the standard if care for cisplatin-eligible patients with MIBC. Developments in the last two decades suggest that bladder sparing therapy may be a valuable alternative to radical cystectomy. Currently, well-documented TMT regimens, which include complete transurethral resection of bladder tumor (TURBT), chemotherapy, and radiation therapy, demonstrated durable oncologic control and long-term survival in selected patients. Nevertheless, TMT has not been widely used in clinical practice. On the one hand, due to the complexity of TMT, multiple clinical departments are required to cooperate in the assessment, treatment and follow-up of patients. On the other hand, concerns about tumor recurrence, lack of surgical intervention in regional lymph nodes, and organ dysfunction due to the treatment of large doses of pelvic radiation have reduced the clinical acceptance of TMT. In recent years, immunocheckpoint inhibitors such as PD-1/L1, including Nivolumab, Pembrolizumab, and Tislelizumab, have proven to be promising immunotherapy approaches for advanced urothelium cancer, leading to breakthroughs in the treatment of advanced urothelium cancer. Immunocheckpoint inhibitors also showed positive efficacy in patients who did not respond to BCG treatment during perioperative period. Therefore, immunotherapy can be another means of bladder preservation after surgery, chemotherapy and radiotherapy. However, bladder sparing target population is still unclear, among which, the NCCN guidelines recommend patients suitable for bladder preservation: T2-3N0M0, single lesion (longest diameter less than 6 cm), histological type of urothelial carcinoma, no CIS, and no hydronephrosis. Therefore, the focus of bladder preservation treatment is not only on the treatment before and during bladder preservation, but also on maximizing the follow-up treatment of TURBT and exploring its long-term benefits based on response to systematic treatment before maximized TURBT.
CONDITIONS
Official Title
Risk-stratification Based Bladder-sparing Modalities for Muscle-invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 85 years
- Desire to preserve the bladder
- ECOG performance status of 0 to 2
- Diagnosed with muscle-invasive bladder urothelial carcinoma by TURBT and imaging (histologic variations accepted, excluding diffuse carcinoma in situ)
- Underwent maximum transurethral resection of bladder tumor (TURBT)
- Clinical stage T2-4A, N0-1, M0
- Normal major organ function within 14 days before enrollment, including:
- Hemoglobin 90 g/L or higher, absolute neutrophil count 1.5 x 10^9/L or higher, platelets 100 x 10^9/L or higher
- Total bilirubin ≤1.5 times upper limit of normal, ALT and AST ≤2.5 times upper limit of normal (≤5 times if liver metastasis)
- Estimated glomerular filtration rate (eGFR) ≥60 mL/min
- INR and aPTT ≤1.5 times upper limit of normal (for patients not on anticoagulants; patients on anticoagulants must be within therapeutic range)
- Use of effective contraception during the study and for 12 months after treatment if fertile
- Voluntary consent and ability to comply with study and follow-up procedures
You will not qualify if you...
- Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 therapies
- Known allergy to recombinant humanized anti-PD-1 monoclonal antibodies or components
- Received other anticancer therapies, including corticosteroids, within 4 weeks before study therapy
- Participation in other clinical trials without recovery from prior toxicity (except for mild hair loss or neurotoxicity)
- Pregnant or breastfeeding women, or women planning pregnancy
- HIV positive status
- Active hepatitis B or C infection
- History of active tuberculosis
- Active autoimmune disease requiring systemic treatment within the past 2 years
- Use of systemic corticosteroids or immunosuppressants except permitted alternatives
- Serious uncontrolled illnesses that may affect study compliance or data interpretation
- Recent live vaccine within 4 weeks before treatment
- Prior allogeneic stem cell or solid organ transplantation
- History of psychotropic drug abuse or mental disorders
- Large symptomatic pleural effusion or ascites requiring treatment
- Other malignancies within the past 5 years except certain low-risk cancers
- Prior pelvic radiation therapy
- Upper tract urothelial carcinoma or urethral cancer
- Any other serious medical or mental condition increasing study risk or interfering with results
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
Y
Yijun Shen, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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