High-risk non-muscle-invasive bladder cancer
Conditions
Interventions
Experimental Group (Phase II):Intravesical Instillation of BCG combined with Serplulimab
Dose escalation group (phase I):Intravesical Instillation of BCG combined with Serplulimab
Sponsors
Sichuan Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18-75 years at the time of signing the informed consent; 2. Postoperative pathological histologic diagnosis of high-risk non-muscle-invasive bladder cancer, if the histology is mixed, the patient should meet the histological type, mainly urothelial (>50%); 3. Ensure complete resection of the tumor at the time of enrollment (residual CIS is acceptable); 4. Secondary TURBT is acceptable, but the interval between the two TURBTs should be 2-6 weeks; 5. Imaging evidence (CT or MRI) within 3 months prior to enrollment excludes locally advanced bladder tumors, upper tract urothelial tumors, other distant metastases, etc.; 6. ECOG score of 0-1 points; 7. Patients should be able to provide blood and urine samples, biopsy or electroresection of tumor tissue; 8. Ensure that the hematopoietic function of organs and bone marrow is normal: hemoglobin > = 90 g/L; Number of neutrophils>=1.5×10^9/L (no granulocyte colony-stimulating factor treatment within 2 weeks); Number of lymphocytes >=0.5×10^9/L; Number of platelets >=100×10^9/L (no blood transfusion within 2 weeks); The number of white blood cells is between 4.0~15.0*10^9/L; alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase 60ml/min; 9. Females of childbearing age should ensure that they are not pregnant before enrollment, and pay attention to contraception during the test.
Exclusion criteria
Exclusion criteria: 1. Prior immunotherapy targeting PD-1 or PD-L1 (or other immune checkpoint inhibitors); 2. Previous BCG bladder infusion therapy; 3. Muscle-invasive (>= T2), locally advanced inoperable resectable, or metastatic urothelial carcinoma; with urothelial carcinoma of the upper tract (UTUC); 4. Received photodynamic therapy, systemic chemotherapy, molecular targeted therapy, immunotherapy or radiotherapy for bladder tumors; 5. Clinical trials with any other investigational drugs within 4 weeks prior to enrollment; 6. Patients with other malignant tumors within 5 years; 7. Those with a history of severe allergies, severe allergic reactions to other chimeric or humanized antibodies, fusion proteins and other drugs; 8. Active tuberculosis; 9. Patients with other autoimmune diseases and receiving systemic therapy within 2 years; 10. Patients requiring systemic anti-infective therapy due to uncontrolled infection within 1 week prior to enrollment; 11. Known human immunodeficiency virus infection; 12. Active hepatitis B (positive hepatitis B surface antigen test and HBV DNA >=500 IU/mL); 13. Active hepatitis C (positive HCV antibody test and HCV virus copy number greater than the upper limit of normal); 14. History of active autoimmune disease or autoimmune disease that may relapse (myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, glomerulonephritis); 15. Patients with a history of vaccination within 30 days prior to enrollment; 16. Prior allogeneic stem cell transplantation or organ transplantation; 17. Long-term oral steroid hormones must be stopped for more than 28 days; 18. Clinically significant cardiovascular disease, such as cardiac disease (grade II or above) graded by the New York Heart Association, myocardial infarction, unstable arrhythmia, or unstable angina pectoris occurred within 3 months prior to enrollment; 19. History of idiopathic pulmonary fibrosis (including non-infectious pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia) or active pneumonia on chest CT scan during the screening period. 20. Patients who have undergone major surgery under general anesthesia within 4 weeks before enrollment, or who plan to undergo surgery during the course of this trial (except for TURBT and biopsy); 21. Other patients who, in the opinion of the possible investigator, are not conducive to the study treatment or are not suitable for entry into this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cystectomy-free survival;Progression-Free Survival;Adverse event; | — |
Countries
China
Contacts
Public ContactLiao Hong
Sichuan Provincial Cancer Hospital
Outcome results
None listed