Cryoablation Versus BCG Instillation Therapy for High-risk NMIBC

Bladder Cancer Clinical Trial

Official title:

A Prospective, Multicenter, Randomized Controlled Clinical Study Evaluating the Safety and Efficacy of Cryoablation Versus BCG Instillation Therapy for High-risk NMIBC

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06324058
• Other study ID #: Huashan_H
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 18, 2024
• Est. completion date: March 18, 2026

Study information

• Verified date: March 2024
• Source: Huashan Hospital
• Contact: Shenghua Liu, Dr.
• Phone: +8618101881202
• Email: 08301010098[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 190
• Est. completion date: March 18, 2026
• Est. primary completion date: March 18, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Procedure:
• 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.
• Transurethral resection of bladder tumor
Resection of bladder tumor using resectoscopy, which is a standard procedure to treat non-muscle invasive bladder cancer

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor residual rate	10-12 weeks after the initial TUR, Re-TUR or cystoscopy is performed on the original resection site, and a biopsy of the tissue at the original resection site is conducted to analyze and observe whether there is any tumor residue at the original tumor site.	10-12 weeks after initial TURBt
Secondary	Recurrence	Non-muscle invasive bladder cancer recurrence during follow-up	2 years
Secondary	Progression	Muscle invasive bladder cancer recurrence during follow-up	2 years