Cryoablation Versus BCG Instillation Therapy for High-risk NMIBC

NCT ID: NCT06324058

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-18
• Study Completion Date: 2026-03-18

Brief Summary

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.

Conditions

Bladder Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cryoablation group

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

Group Type: EXPERIMENTAL

Transurethral cryoablation

Intervention Type: PROCEDURE

Using an intracavitary cryoablation balloon, cryoablation is performed on the wound surface after tumor resection. The wound surface is frozen for 2 rounds, with each round lasting 3 minutes, to fully cover the wound surface.

Transurethral resection of bladder tumor

Intervention Type: PROCEDURE

Resection of bladder tumor using resectoscopy, which is a standard procedure to treat non-muscle invasive bladder cancer

Bcg Intravesical

Intervention Type: DRUG

Bacillus Calmette-Guerin instillation of bladder after surgery according to the NCCN bladder cancer guidelines. At least 6 weeks induction instillation is required for high-risk NMIBC patients. At least 1 year maintenance instillation is recommended.

Control group

Transurethral resection of bladder tumor, conventional BCG instillation after surgery

Group Type: ACTIVE_COMPARATOR

Transurethral resection of bladder tumor

Intervention Type: PROCEDURE

Resection of bladder tumor using resectoscopy, which is a standard procedure to treat non-muscle invasive bladder cancer

Bcg Intravesical

Intervention Type: DRUG

Bacillus Calmette-Guerin instillation of bladder after surgery according to the NCCN bladder cancer guidelines. At least 6 weeks induction instillation is required for high-risk NMIBC patients. At least 1 year maintenance instillation is recommended.

Interventions

Transurethral cryoablation

Using an intracavitary cryoablation balloon, cryoablation is performed on the wound surface after tumor resection. The wound surface is frozen for 2 rounds, with each round lasting 3 minutes, to fully cover the wound surface.

Intervention Type: PROCEDURE

Transurethral resection of bladder tumor

Resection of bladder tumor using resectoscopy, which is a standard procedure to treat non-muscle invasive bladder cancer

Intervention Type: PROCEDURE

Bcg Intravesical

Bacillus Calmette-Guerin instillation of bladder after surgery according to the NCCN bladder cancer guidelines. At least 6 weeks induction instillation is required for high-risk NMIBC patients. At least 1 year maintenance instillation is recommended.

Intervention Type: DRUG

Other Intervention Names

TURBt

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huashan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Haowen Jiang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haowen Jiang, Pro.

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital

Central Contacts

Shenghua Liu, Dr.

Role: CONTACT

08301010098@fudan.edu.cn

+8618101881202

Other Identifiers

Huashan_H

Identifier Type: -

Identifier Source: org_study_id