Bladder cancer patients may get new hope from virus treatment

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Voluntarily participate in this clinical study, understand the study procedures, and provide written informed consent. * Aged ≥18 years, regardless of gender. * Eastern Cooperative Oncology Group (ECOG) performance status score ≤2. * Expected survival time ≥2 years. * Histologically confirmed high-risk non-muscle invasive bladder cancer (NMIBC) ("high-risk" defined in Appendix 1 ). * No residual lesions after cystoscopy or transurethral resection of bladder tumor (TURBT) within 6 weeks prior to the first dose, or residual lesions limited to carcinoma in situ (CIS). * Adequate Hematologic and Organ Function : Hematologic (no blood transfusion, growth factors, or hematopoietic stimulants within 14 days): Absolute neutrophil count (ANC) ≥1.0×10⁹/L; Platelet count (PLT) ≥100×10⁹/L; Hemoglobin (Hb) ≥80 g/L. Liver Function : Total bilirubin (TBIL) ≤2×ULN; Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤3×ULN. Renal Function : Serum creatinine (Cr) ≤1.5×ULN. Electrocardiogram (ECG) : QTc interval ≤450 ms (male) or ≤470 ms (female), corrected by Fridericia's formula (QTc = QT/(RR⁰·³³)). Cardiac Ultrasound : Left ventricular ejection fraction (LVEF) ≥50%. Coagulation : Activated partial thromboplastin time (APTT) ≤1.5×ULN; International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN. Contraception Requirements * Non-sterilized participants of childbearing potential (male or female) must agree to use effective contraception (e.g., intrauterine device, oral contraceptives) during the study and for 3 months after treatment. Female participants (or female partners of male participants) must use highly effective contraception. * Non-sterilized female participants must have a negative serum HCG test within 7 days before the first dose and must not be lactating. Exclusion Criteria: * Prior Bladder Radiotherapy * Prior Treatments Without Disease Progression (as Assessed by Investigator) * Previous intravesical therapy with cytotoxic chemotherapy or other agents (e.g., oncolytic viruses, IL-2). * Systemic chemotherapy, immune checkpoint inhibitors, or antibody-drug conjugates (ADCs). * Participation in other investigational drug trials for NMIBC. * Intravesical Bacillus Calmette-Guérin (BCG) treatment within 2 weeks before the first dose (eligible if washout period exceeds 2 weeks). * Currently receiving investigational treatment in another clinical trial or completion of such treatment \<4 weeks before the first dose in this study. * Upper urinary tract or urethral tumors detected during screening ( CTU/MRU ). Other malignancies within 5 years before the first dose (exceptions: completely resolved carcinoma in situ or indolent malignancies like prostate cancer, per investigator's judgment). * Active severe infections requiring IV antibiotics, antivirals, or antifungals. Grade ≥3 urinary tract infection (UTI) not recovered to Grade ≤2. * Previous BCG therapy discontinued due to adverse events (e.g., sepsis, systemic infection, urinary incontinence) unless fully recovered to Grade ≤2 . * Clinically Significant Cardiovascular Disease , including but not limited to: Congestive heart failure ( NYHA Class \>2 ); Unstable angina; Severe myocardial infarction within 6 months ; Symptomatic arrhythmias requiring intervention. * Immunodeficiency or Transplant History , including HIV-positive serology and other acquired/congenital immunodeficiencies. * History of organ transplantation or current immunosuppressant use. * Active Viral Hepatitis Hepatitis B : HBeAg-positive and HBV DNA ≥500 IU/mL. Hepatitis C : Anti-HCV-positive and HCV RNA above the lower limit of detection. Hypersensitivity or Intolerance * Known allergy or intolerance to the study drug or its excipients. * Any other severe physical/psychiatric illness, abnormal lab results, or factors that may: Increase study participation risks; Interfere with study results; Investigator's discretion for ineligibility.