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.
Patients between 18 and 75 years old on day of signing informed consent, regardless of gender;
ECOG score 0-1 points, expected survival time> 6 months;
Pathologically confirmed locally advanced bladder urothelial carcinoma (cT2-T4a, N≤1, M0, tumor staging according to American Joint Committee on Cancer (AJCC), 2017, eighth edition);
Appropriate and plan for radical cystectomy;
Have previously received anti-PD1/PDL1/CTLA-4 antibody treatment or systemic chemotherapy, bladder infusion chemotherapy is excluded;
Have received bladder bacille Calmette Guerin (BCG) infusion therapy within 4 weeks;
Have received radiotherapy of the bladder in the past;
Patients with any history of active autoimmune disease or autoimmune disease;
Single group
Neoadjuvant Toripalimab in Combination With Gemcitabine and Cisplatin
Drug4 cycle neoadjuvant therapy and radical cystectomy
Pathological response rate evaluated after 4 cycles of neoadjuvant Toripalimab in combination with gemcitabine and cisplatin at time of radical cystectomy, each cycle is 21 days
the absence of residual muscle invasive bladder cancer in surgical specimens of cystectomy (pathologically decreased to ≤pT1N0, including pT0, pT1, pTa and pTis
Safety assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4 criteria
To assess safety of Toripalimab in combination with gemcitabine and cisplatin in patients with bladder cancer according to CTCAE v4 criteria
Progression-free survival assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1
From the start of neoadjuvant therapy to the time when any disease progression is first recorded, disease progression includes the progression detected by clinical or imaging before cystectomy, as well as the distant metastasis or pelvic recurrence after cystectomy. Newly discovered primary tumors in other parts of the urinary tract such as renal pelvis, ureter and urethra are not considered as disease progression.
Tumor immune microenvironment indicators assessed by Microenvironment Analysis Panel
The expression rate of PDL1 in pathological specimens assessed by Burning Rock's product OncoScreen plus+Microenvironment Analysis Panel at the time of surgery
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