OncoMatch/Clinical Trials/NCT04861584
Neoadjuvant Toripalimab in Combination with Gemcitabine and Cisplatin Therapy in Local Advanced Bladder Cancer Subjects
Is NCT04861584 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Neoadjuvant Toripalimab in Combination With Gemcitabine and Cisplatin for urinary bladder cancer.
Treatment: Neoadjuvant Toripalimab in Combination With Gemcitabine and Cisplatin — This is a pre-surgical study involving subjects with local advanced bladder cancer, who are candidates for neoadjuvant therapy. It is a single-arm phase II portion.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1 therapy
Have previously received anti-PD1/PDL1/CTLA-4 antibody treatment
Cannot have received: anti-PD-L1 therapy
Have previously received anti-PD1/PDL1/CTLA-4 antibody treatment
Cannot have received: anti-CTLA-4 therapy
Have previously received anti-PD1/PDL1/CTLA-4 antibody treatment
Cannot have received: systemic chemotherapy
Exception: bladder infusion chemotherapy is excluded
Have previously received ... systemic chemotherapy, bladder infusion chemotherapy is excluded
Cannot have received: bladder bacille Calmette Guerin (BCG) infusion therapy
Have received bladder bacille Calmette Guerin (BCG) infusion therapy within 4 weeks
Cannot have received: radiation therapy
Exception: bladder only
Have received radiotherapy of the bladder in the past
Lab requirements
Blood counts
WBC≥4.0×10^9/L; PLT≥90×10^9/L; Hb≥90g/L (patients can be infused with red blood cells to meet this standard)
Kidney function
serum creatinine (Cr) ≤1.5 times the upper limit of normal (ULN) or endogenous creatinine clearance ≥60mL/min
Liver function
TBIL≤1.5×ULN; ALT and AST≤ 3.0×ULN
Routine blood examination must meet: WBC≥4.0×10^9/L; PLT≥90×10^9/L; Hb≥90g/L ... Blood biochemical examination must meet: serum creatinine (Cr) ≤1.5 times the upper limit of normal (ULN) or endogenous creatinine clearance ≥60mL/min; TBIL≤1.5×ULN; ALB≥30g/L; ALT and AST≤ 3.0×ULN; TSH≤1.5×ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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