Cryoablation Versus BCG Instillation Therapy for High-risk NMIBC

N/ANot Yet RecruitingNCT06324058

Huashan Hospital190 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

190

Conditions

Bladder Cancer

Interventions

Transurethral cryoablationPROCEDURE

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 tumorPROCEDURE

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

Bcg IntravesicalDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 10-12 weeks after initial TURBt

Secondary Outcomes

Recurrence

Non-muscle invasive bladder cancer recurrence during follow-up

Time frame: 2 years

Progression

Muscle invasive bladder cancer recurrence during follow-up

Time frame: 2 years

Central Contacts

Shenghua Liu, Dr.

CONTACT

+8618101881202 08301010098@fudan.edu.cn

Data from ClinicalTrials.gov

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