Status:
UNKNOWN
Chemotherapy Combined With Tislelizumab as Bladder Sparing Option for Patients With Muscle Invasive Bladder Cancer
Lead Sponsor:
Ruijin Hospital
Conditions:
Muscle-Invasive Bladder Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study is designed prospectively to investigate the safety, efficacy and feasibility of cisplatin-based chemotherapy combined with tislelizumab as bladder sparing treatment for patients with muscl...
Detailed Description
The patients that meet the Inclusion and Exclusion Criteria will treat with 4 cycles of cisplatin-based chemotherapy combined with Tislelizumab (200mg per cycle) prior to cystectomy discussion. The pa...
Eligibility Criteria
Inclusion
- ≥ 18 and ≤75 years old on day of signing informed consent
- Signing informed consent
- Patients with histologically confirmed muscle-invasive bladder cancer (cT2-T4, N0, M0) and with strong intent to bladder sparing(Patients with mixed histology, predominantly transitional cells, could be enrolled. )
- Patients must be willing to provide a TURBT specimen during screening and prior to enrollment if adequate specimen (FFPE tissue block or 15 unstained slides) from initial TURBT documenting muscle-invasive urothelial bladder cancer is not available.
- ECOG performance status of 0 or 1
- Adequate organ and marrow function for cisplatin treatment
- No received prior therapy with systemic chemotherapy or immunotherapy
Exclusion
- Received prior therapies targeting PD-1, PD-L1, PD-L2, CTLA4, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- Any approved anticancer therapy within 28 days before enrollment
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis
- Participants with uncontrolled hypercalcemia
- Participants with active autoimmune diseases or history of autoimmune diseases that may relapse
- History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled diseases
- A known history of HIV infection
- Prior allogeneic stem cell transplantation or organ transplantation
- History of severe hypersensitivity reactions to other monoclonal antibodies
- History of allergic reactions to cisplatin, carboplatin, or other platinum-containing compounds
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04909775
Start Date
July 1 2021
End Date
July 1 2023
Last Update
June 2 2021
Active Locations (1)
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1
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China