Cryoablation Versus BCG Instillation Therapy for High-risk NMIBC

Fudan University

Status: Not yet enrolling

Conditions: Bladder Cancer

Treatments: Drug: Bcg Intravesical; Procedure: Transurethral cryoablation; Procedure: Transurethral resection of bladder tumor

Study type: Interventional

Funder types: Other

Identifiers

NCT06324058

Huashan_H

Details and patient eligibility

About

This trial plans to enroll 190 eligible patients and randomize them into two groups with a 1:1 ratio, with 95 patients in each group. The experimental group will receive immediate cryoablation therapy at the resection site after TUR, while the control group will only undergo TUR and receive conventional BCG instillation therapy postoperatively. Both groups of subjects will undergo Re-TURBT or cystoscopy 10-12 weeks after surgery to compare the tumor-free residual rates and adverse events between the two groups.

Enrollment: 190 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged between 18 and 85, male or female;
2. Preoperatively diagnosed with T1 stage or meeting the criteria for high-risk bladder cancer (accord with the "2023 NCCN Bladder Cancer Guidelines");
3. Good compliance and able to cooperate with observation;
4. Able to understand the purpose of the trial, agree to participate in this study, and have signed the informed consent form.

Exclusion criteria

1. Patients with severe infectious diseases such as bacteremia and toxemia;
2. Patients with severe coagulation dysfunction;
3. Patients with severe heart, brain, lung, liver, kidney and other diseases who cannot tolerate surgery;
4. Patients with other concurrent malignancies;
5. Postoperative pathological diagnosis of bladder cancer patients in Tis, Ta, or T2 stages;
6. Preoperative CT/MRI assessment showing tumor invasion beyond the bladder (T3 stage or above);
7. Preoperative assessment indicating distant metastasis or enlarged pelvic lymph nodes;
8. Pregnant or breastfeeding women;
9. Other situations assessed by researchers as unsuitable for inclusion in this study, such as inappropriate anatomical structure, mental or psychological disorders.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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190 participants in 2 patient groups

Cryoablation group

Experimental group

Description:

Transurethral resection of bladder tumor, instant cryoablation of the bladder tumor resection site.

Treatment:

Procedure: Transurethral resection of bladder tumor

Procedure: Transurethral cryoablation

Drug: Bcg Intravesical

Control group

Active Comparator group

Description:

Transurethral resection of bladder tumor, conventional BCG instillation after surgery

Treatment:

Procedure: Transurethral resection of bladder tumor

Drug: Bcg Intravesical