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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 (Jun 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 Jun 2026Location: China

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

Treatments studied

Other

BCG for Therapeutic UseBCG for Therapeutic Use

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)

Demographics

Ages ≤ 75

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.

Frequently asked questions

Is NCT06241755 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior BCG bladder instillation disqualifies patients from enrollment.

What disease stage is eligible?

Stage TIS is required.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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