Bladder cancer
Conditions
Interventions
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years, male or female. 2. Histologically confirmed non-muscle-invasive bladder cancer (NMIBC). 3. Failure of at least one course of BCG or intravesical chemotherapy after transurethral resection of bladder tumor (TURBT), including BCG-unresponsive disease, recurrence after BCG/chemotherapy instillation, or intolerance to BCG/chemotherapy instillation; the patient wishes to preserve the bladder or is not suitable for radical cystectomy. 4. TURBT performed 8 to 2 weeks prior to the first dose, with no visible tumor and negative random biopsies. 5. ECOG performance status (PS) 0–2. 6. Expected survival >= 12 months. 7. Major organ functions are good, and laboratory tests meet the following requirements: (1) Complete blood count: white blood cell count >= 3.0×10^9/L, absolute neutrophil count >= 1.0×10^9/L, hemoglobin >= 80 g/L, platelet count >= 90×10^9/L; (2) Blood biochemistry: ALT and AST <= 3.0×ULN (upper limit of normal), total bilirubin <= 3.0×ULN; serum creatinine <= 1.5×ULN. (3) Coagulation function: PT and APTT <= 1.5×ULN. 8. Women of childbearing potential must agree to use contraception during the study and for 3 months after study completion, and have a negative serum pregnancy test during screening; male subjects must agree to use contraception during the study and for 3 months after study completion. 9. The subject is able to understand and comply with the study procedures and voluntarily signs the informed consent form to participate in this study.
Exclusion criteria
Exclusion criteria: 1. Previous or current diagnosis of muscle-invasive bladder cancer, or evidence of lymph node metastasis or distant metastasis. 2. Concurrent urothelial carcinoma of the upper urinary tract (kidney, renal pelvis/collecting system, ureter) or the prostatic urethra. 3. History of vesicoureteral reflux. 4. Previous or current contraindications to bladder instillation therapy, such as bladder perforation, symptomatic urinary tract infection, urinary incontinence, or other relevant conditions. 5. Active infection, including: (1) Positive hepatitis B surface antigen (HBsAg) or positive hepatitis C virus (HCV) antibody, with HBV DNA or HCV RNA above the lower limit of detection during screening; (2) Known history of HIV infection or positive HIV antibody test at screening; (3) Known history of tuberculosis infection; (4) Other active infections that, in the investigator’s judgment, require treatment with antibiotics, antifungal agents, or antiviral agents. 6. Presence of severe or uncontrolled underlying diseases, such as hypertension, diabetes mellitus, cardiovascular/cerebrovascular disease, pulmonary disease, autoimmune disease, or others. 7. Previous treatment with an adenovirus vector-based investigational product. 8. Any prior surgery, radiotherapy, or systemic antitumor therapy for bladder cancer, other than TURBT. 9. Receipt of a live or attenuated live vaccine within 28 days prior to the first administration of the investigational product. 10. Known hypersensitivity to any component of the investigational product. 11. Pregnant or lactating women, or subjects who wish to become pregnant during the clinical trial period. 12. Any other condition that, in the investigator’s judgment, makes the subject unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT occurrence;Incidence of adverse events (AE), treatment-emergent adverse events (TEAE), treatment-related adverse events (TRAE), and serious adverse events (SAE);Abnormal results and changes over time of physical examination and laboratory tests (complete blood count, blood biochemistry, urinalysis, coagulation function, electrocardiogram, etc.); | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete remission (CR) rate at 3 months and 6 months;Recurrence-Free Survival (RFS);Overall Survival (OS); | — |
Countries
China
Contacts
Public ContactNianzeng Xing
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed