OncoMatch/Clinical Trials/NCT05531123
Risk-stratification Based Bladder-sparing Modalities for Muscle-invasive Bladder Cancer
Is NCT05531123 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Tislelizumab and gemcitabine and cisplatin for bladder cancer.
Treatment: Tislelizumab · gemcitabine and cisplatin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: transurethral resection of bladder tumor
Subject underwent TURBT surgery
Cannot have received: anti-PD-1 therapy
Previously received anti-PD-1, anti-PD-L1, and anti-PD-L2 therapy
Cannot have received: antineoplastic therapy
Received other antineoplastic therapy (including but not limited to corticosteroids) within 4 weeks prior to study therapy
Cannot have received: pelvic radiation therapy
Previous history of pelvic radiation therapy
Cannot have received: allogeneic hematopoietic stem cell transplantation
Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation
Cannot have received: solid organ transplantation
Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation
Lab requirements
Blood counts
HB ≥90 g/L; ANC ≥1.5 x 10^9/L; PLT ≥100 x 10^9/L
Kidney function
Estimated glomerular filtration rate (EGFR) ≥60 mL/min (MdRD formula)
Liver function
T-bil ≤1.5×ULN; ALT and AST≤2.5×ULN; if liver metastasis, ALT and AST≤5×ULN
Normal function of major organs (14 days prior to enrollment)...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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