Neoadjuvant Toripalimab in Combination with Gemcitabine and Cisplatin Therapy in Local Advanced Bladder Cancer Subjects

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhujiang Hospital

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

Treatment groups

41 Participants
are divided into 1 treatment group

Sponsors and collaborators