Muscle-invasive Bladder Cancer, Upper Tract Urinary Carcinoma
Conditions
Keywords
upper tract urinary carcinoma, muscle-invasive bladder cancer, neoadjuvant, chemotherapy, immunotherapy
Brief summary
Few previous studies focused on the neoadjuvant treatments of upper urinary or bladder cancer, especially chemotherapy combined with immunotherapy, however, available data of retrospective studies showed this neoadjuvant treatment model might benefit patients. So This prospective Phase II clinical trial was designed to explore the efficacy of chemotherapy combined with PD-1 inhibitor as neoadjuvant therapy in upper urinary and muscle-invasive bladder urothelial carcinoma, then to improve the rate of complete pathological remission, survival and provide medical evidence.
Interventions
DRUGToripalimab
Gemcitabine/Cisplatin plus Toripalimab
Sponsors
Peking University First Hospital
China-Japan Friendship Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. bladder cancer of T2-4aN0M0 2. upper tract urinary carcinoma of T1-3N0M0 and high grade 3. ECOG 0-1 4. good organ function 5. no previous chemotherapy or immunotherapy 6. Informed consent form signed
Exclusion criteria
1. unable to receive chemotherapy or surgery due to physical abnormalities 2. previous cancer history 3. active tuberculosis 4. HIV 5. autoimmune disease 6. anticipating other clinical studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pathological complete response rate | through study completion of 3 years | the percentage of pT0N0 patients after operations |
Countries
China
Contacts
Primary ContactJianzhong Shou
Outcome results
None listed