bladder cancer
Conditions
Interventions
sing-arm:RC48 and Envafolimab
Sponsors
The First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. male or female, aged >= 18 years, > 75 years patients are eligible at the investigator's discretion; 2. informed consent has been signed; 3. bladder cancer: invasive urothelial carcinoma of the bladder without distant metastasis (T2-T4aN = T2; 7. the ECOG physical status score was 0-1; 8. Renal function: GFR >= 45ml/min; 9. Patients are deemed by the investigators to be candidates for treatment with RC48 and emvolumab; 10. At least one measurable lesion in the bladder; 11. women of child-bearing age must be willing to use adequate contraception during research drug treatment.
Exclusion criteria
Exclusion criteria: 1. Patients with known allergies to the components of the study drugs; 2. RC48 or PD-1/PD-L1 inhibitor drugs were used before; 3. Treated with other study drugs with 28 days before enrollment; 4. Patients with grade =1 peripheral neuropathy according CTCAE V 5.0; 5. Combined with other malignant tumors under treatment; 6. Patients with active tuberculosis; 7. Severe infections occurred within 4 weeks before enrollment; 8. Patients with HIV infection, patients with active HBV and HCV; 9. Active autoimmune disease or potentially relapsing autoimmune disease; 10. Clinically significant cardiovascular disease; 11. LVEF < 40%; 12. History of allogeneic stem-cell or organ transplantation; 13. Patients with dementia, altered mental status, or any psychiatric illness that would prevent understanding or giving informed consent or filling out questionnaires; 14. Laboratory tests with any symptoms, treatments, or abnormalities that may interfere with the judgment of the results of the study, interfere with the enrollment of the subjects, or are not in the best interest of the subjects; 15. Underlying medical conditions that considered to be detrimental to the study treatment or difficult to explain in terms of drug toxicity or adverse events by the investigator; 16. Other conditions are inappropriate for enrollment considered by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| pDS;ORR;DFS;OS; | — |
Countries
China
Contacts
Public ContactBaiye Jin
The First Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed