bladder cancer
Conditions
Interventions
Experimental group:SSHR1501 and BCG vaccine
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in this clinical study, understand the research procedures and be able to sign written informed consent; 2. Aged >= 18 years; 3. The pathological tissue biopsy was diagnosed as high-risk NMIBC within 3 months before the first administration; 4. There are no resectable lesions under cystoscopy within 6 weeks before the first administration, or the remaining lesions are low-grade Ta or CIS; 5. No previous BCG treatment or no response to BCG treatment; 6. The Eastern Cooperative Oncology Group (ECOG) performance status score is 0, 1, or 2; 7. Appropriate organ function.
Exclusion criteria
Exclusion criteria: 1. Receiving chemotherapy bladder perfusion or radiotherapy within 2 weeks before the first administration; 2. Receive systemic immunosuppressive therapy within 2 weeks before the first administration; 3. The upper urinary tract tumor was found in the upper urinary tract examination during the screening period, or other malignant tumors were combined within 5 years of the first administration; 4. The researcher thinks that it is not suitable to participate in any other situations in this research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity;Maximum tolerated dose;Complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of remission;Progression-free survival; | — |
Countries
China
Contacts
Public ContactGuo Jianming
Zhongshan Hospital, Fudan University
Outcome results
None listed