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OncoMatch/Clinical Trials/NCT06241755

Clinical Trial for Evaluating the Efficacy and Safety of BCG for Therapeutic Use in the Prevention of Postoperative Recurrence of Medium/High-risk Non-muscle Invasive Bladder Cancer (NMIBC)

Is NCT06241755 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including BCG for Therapeutic Use and BCG for Therapeutic Use for non-muscle invasive bladder cancer.

Phase 3RecruitingChengdu CoenBiotech Co., LtdNCT06241755Data as of May 2026

Treatment: BCG for Therapeutic Use · BCG for Therapeutic UseA phase III multi-center randomized, double-blind and positive-controlled clinical trial for evaluating the efficacy and safety of BCG for Therapeutic Use(BCG) in the prevention of postoperative recurrence of medium/high-risk non-muscle invasive bladder cancer (NMIBC).

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Extracted eligibility criteria

Cancer type

Urothelial Carcinoma

Disease stage

Required: Stage TIS

Excluded: Stage MUSCLE INVASIVE, FOCAL ADVANCED, METASTATIC MUSCULAR INFILTRATION

Grade: G3 (advanced grade) tumor, except for simple in situ tumor

medium/high-risk non-muscle invasive urothelial bladder cancer (T1/Ta/Tis)

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Must have received: transurethral resection of bladder tumor (TURBt)

After a thorough TURBt, all tumors should be grossly invisible. Patients requiring a second procedure are also eligible for inclusion.

Cannot have received: BCG bladder instillation

A previous history of never receiving any therapy of BCG bladder instillation

Lab requirements

Blood counts

ANC ≥1500/mm3 or ≥1.5×10^9/L; platelet ≥100000/mm3 or 100×10^9/L; hemoglobin ≥9 g/dL

Kidney function

estimated creatinine clearance ≥50 mL/min according to the formula of Cockcroft-Gault

Liver function

total serum bilirubin ≤1.5× ULN; for subjects with Gilbert syndrome total serum bilirubin <3×ULN; AST/ALT ≤2.5×ULN

Clinical laboratory tests fulfilling the following features: ... see above

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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