OncoMatch/Clinical Trials/NCT06747455
BCG for Therapeutic Use Phase Ⅲ Clinical Trial
Is NCT06747455 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including BCG for Therapeutic Use and BCG for Therapeutic Use ( BI SAI JI ) for bcg.
Treatment: BCG for Therapeutic Use · BCG for Therapeutic Use ( BI SAI JI ) — Research topic: A randomized, double-blind, active-controlled, multicenter phase III clinical trial evaluating the efficacy and safety of therapeutic BCG for the prevention of postoperative recurrence of non-muscle-invasive bladder cancer in people aged 18 years and older. The name of the drug: Bacillus Calmette-Guérin for treatment(BCG). Clinical indications: It is used for the treatment of bladder carcinoma in situ and the prevention of recurrence, and for the prevention of recurrence of bladder papilloma after transurethral resection in Ta or T1 stage. This product is not used for papillomas beyond the T1 stage. Study population: Patients aged 18 years and above with intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC) who have undergone transurethral bladder tumor resection. Objectives: Primary Objectives: To assess the effectiveness of BCG for therapeutic use in the adjuvant treatment of intermediate- and high-risk NMIBC after transurethral resection of bladder tumors. Secondary Purpose: To assess the safety of the therapeutic BCG vaccine in the adjuvant treatment of intermediate- and high-risk NMIBC after transurethral resection of bladder tumors. Other purposes: To assess the pharmacodynamic (PD) profile of BCG for therapeutic use in the adjuvant treatment of intermediate- and high-risk NMIBC after transurethral resection of bladder tumors. Study design: This study adopts a randomized, double-blind, active-controlled, multi-center trial design, including three phases: screening period, treatment period and follow-up period. In this study, 438 subjects will be randomly assigned to the experimental group and the control group in a 1:1 ratio, with 219 patients in both the experimental group and the control group, and stratified according to the baseline risk level (high-risk/intermediate-risk) and whether or not to perform urine PD sample collection (yes/no).
Check if I qualifyExtracted eligibility criteria
Disease stage
Required: Stage TIS
Excluded: Stage ≥ T2
Grade: high-grade (G3)
T1, Ta or Tis; high-grade (G3) tumors
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: transurethral bladder tumor resection
Patients undergoing transurethral bladder tumor resection need to meet the requirements of all tumors to have no visible tumors after surgery
Cannot have received: BCG
Those who have received any BCG treatment for NMIBC in the past
Cannot have received: systemic anti-tumor treatments (chemotherapy, radiotherapy, immunotherapy)
Exception: immediate postoperative intravesical chemotherapy
patients who have received other systemic anti-tumor treatments such as chemotherapy, radiotherapy, and immunotherapy for the disease under study
Lab requirements
Blood counts
ANC ≥1500/mm³ or ≥1.5×10⁹/L; Platelets ≥100000/mm³ or 100×10⁹/L; Hemoglobin ≥9 g/dL; no hematopoietic growth factors or blood transfusion support within 14 days before randomization
Kidney function
creatinine clearance ≥ 30 mL/min (Cockcroft Gault formula)
Liver function
total bilirubin ≤ 1.5× ULN (Gilbert's syndrome <3× ULN), AST and ALT ≤ 2.5× ULN
Blood routine: no use of hematopoietic growth factors or blood transfusion support within 14 days before randomization, including: absolute neutrophil count (ANC) ≥1500/mm³ or ≥1.5×10⁹/L; Platelets≥ 100000/mm³ or 100×10⁹/L; Hemoglobin ≥ 9 g/dL. Liver function: total bilirubin ≤ 1.5× ULN, subjects with Gilbert's syndrome require total bilirubin <3×ULN, AST and ALT ≤ 2.5×ULN. Renal function: creatinine clearance ≥ 30mL/min. Coagulation function: APTT ≤ 1.5×ULN, INR ≤ 1.5×ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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