Patients 18 years of age and older with medium or high risk non-muscular invasive bladder cancer (NMIBC) after resection of a transurethral bladder tumor
Conditions
Interventions
Trial group:Therapeutic BCG vaccine (Produced by Anhui Zhifei Longkema Biopharmaceutical Co., LTD.)
Control group:BCG vaccine for treatment (Bisaji)
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years old, male or female; 2.According to the Guidelines for the Diagnosis and Treatment of Bladder Cancer (2022 Edition), the initial histologic diagnosis of intermediate- and high-risk non-muscle-invasive urothelial carcinoma of the bladder (T1, Ta or Tis) and the need for BCG bladder infusion adjuvant therapy are evaluated; 3.Patients undergoing transurethral resection of bladder tumors need to meet the requirements of all tumors to have no visible tumors after surgery. This study can also enroll patients who need a second electroresection, and subjects who meet the criteria for a second resection should undergo a second resection, which should be included in the study after a comprehensive evaluation of the two pathological results (BCG perfusion for treatment should be carried out within 2~12 weeks after surgery, cystoscopy should be added more than 4 weeks after surgery to ensure that there is no visible tumor after surgery, and the subjects who underwent secondary resection should be calculated based on the postoperative time of the second electroresection); Note: The criteria for the second resection: 1.the first TURBt is insufficient; 2.the first electrosection of non-myometrial tissue specimens; 3. T1 tumors; 4.High-grade (G3) tumors, except for carcinoma in situ. The second resection is recommended to be performed within 2-6 weeks after the first resection, and no other perfusion therapy is allowed except for the bladder infusion chemotherapy drugs immediately after the first and second resection; 4.Eastern Cooperative Oncology Group (ECOG) score (see Appendix 1 for details): 0~2 points; 5.At screening, clinical laboratory tests consistent with the following characteristics: Routine blood count: no use of hematopoietic growth factors or transfusion support within 14 days prior to randomization, including: absolute neutrophil count (ANC) >=1500/mm^3 or>= 1.5×10^9/L; Platelets>= 100000/mm^3 or 100×10^9/L; Hemoglobin >=9 g/dL. Liver function: total bilirubin = 30 mL/min; Coagulation function: activated partial thromboplastin time (APTT) <= 1.5×ULN, international normalized ratio (INR) <=1.5×ULN. 6.Voluntarily participate in this trial with full informed consent and signed written informed consent;
Exclusion criteria
Exclusion criteria: 1. Patients with immunodeficiency or impairment (e.g., AIDS patients), those currently receiving immunosuppressive drugs, corticosteroids, or other agents that may cause systemic BCG disease reactions (patients receiving replacement hormone therapy due to thyroid/adrenal resection are eligible); 2. Patients allergic to BCG or its excipients; 3. Patients with active tuberculosis or who have received anti-tuberculosis treatment within the past 6 months prior to screening; 4. Patients with severe cardiovascular, cerebrovascular, hepatic, pulmonary, or renal diseases at screening; 5. Patients with concurrent malignancies of the urinary or reproductive system or other organs; patients with previously treated, non-progressive, stable tumors may be considered for inclusion, such as adequately treated basal cell or squamous cell skin cancer; breast or cervical carcinoma in situ; low-grade prostate cancer under active surveillance without any planned intervention (e.g., surgery, radiation, or castration); and other concurrent malignancies deemed by the investigator to have negligible progression risk; 6. Patients with histologically confirmed muscle-invasive, locally advanced, unresectable, or metastatic urothelial carcinoma or a history thereof (i.e., >=T2); 7. Patients previously treated with any BCG therapy for NMIBC; 8. Patients with known or suspected intraoperative bladder perforation or other abnormal conditions; 9. Patients with suspected incomplete surgical wound healing or damaged urothelial mucosa; 10. Patients with cystitis (e.g., presenting with urinary frequency, urgency, or dysuria) as assessed by the investigator, or those with severe bladder irritation symptoms following prior intravesical drug therapy, which may interfere with study evaluation; 11. Patients who received chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to first dosing (except immediate postoperative intravesical chemotherapy); 12. Pregnant or lactating women; 13. Patients unable to guarantee effective contraception from first dosing through 6 months after the last dose; 14. Patients who received other investigational drugs (excluding placebo) or investigational medical devices within 3 months prior to first dosing; 15. Patients with a history of alcohol abuse, drug abuse, or intravenous drug use within the past 6 months; 16. Patients with any of the following: positive HIV antibody, positive syphilis-specific antibody, active hepatitis B (HBsAg positive and HBV DNA >=200 IU/mL or 1000 copies/mL), or positive HCV antibody with HCV viral load >10^3/mL above the laboratory upper limit of normal; 17. Any other condition deemed by the investigator to increase subject risk or interfere with trial conduct.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| One-year recurrence-free survival rate (one-year RFS%); | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year recurrence-free survival rate (2-year RFS%);One-year progression-free survival rate (one-year PFS%);2-year progression-free survival rate (2-year PFS%); | — |
Countries
China
Contacts
Public ContactYe Dingwei
Fudan University Shanghai Cancer Center
Outcome results
None listed