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 (Jun 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
Treatments studied
Chemotherapy
Cancer type
Urothelial Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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.
Frequently asked questions
Is NCT04861584 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages