About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Neoadjuvant Toripalimab in Combination With Gemcitabine and Cisplatin