Cryoablation Versus BCG Instillation Therapy for High-risk NMIBC

NCT06324058 | Not Yet Recruiting

• 1 other identifier: Huashan_H
• Study Type: interventional
• Target: 190
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Recurrence

  2 years

• Progression

  2 years

Study Arms (2)

Cryoablation group

EXPERIMENTAL

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

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

Control group

ACTIVE COMPARATOR

Transurethral resection of bladder tumor, conventional BCG instillation after surgery

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

Interventions

Transurethral cryoablation 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.

Cryoablation group

Transurethral resection of bladder tumor PROCEDURE

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

Also known as: TURBt

Control group; Cryoablation group

Bcg Intravesical 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; Cryoablation group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with severe infectious diseases such as bacteremia and toxemia;
• Patients with severe coagulation dysfunction;
• Patients with severe heart, brain, lung, liver, kidney and other diseases who cannot tolerate surgery;
• Patients with other concurrent malignancies;
• Postoperative pathological diagnosis of bladder cancer patients in Tis, Ta, or T2 stages;
• Preoperative CT/MRI assessment showing tumor invasion beyond the bladder (T3 stage or above);
• Preoperative assessment indicating distant metastasis or enlarged pelvic lymph nodes;
• Pregnant or breastfeeding women;

Sponsors & Collaborators

• Huashan Hospital: lead

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Transurethral Resection of Bladder

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Haowen Jiang, Pro.

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shenghua Liu, Dr.

CONTACT

+8618101881202; 08301010098@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 10, 2024
• First Posted: March 21, 2024
• Study Start: March 18, 2024
• Primary Completion: March 18, 2025
• Study Completion: March 18, 2026
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share