Investigation Into the Integration of Intracavitary Cryoablation and Immunotherapy in Bladder-Preserving Therapy

NARecruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

September 1, 2027

Study Completion Date

September 1, 2027

Conditions
Bladder Cancer
Interventions
PROCEDURE

TURBT combined with cryoablation-assisted postoperative immunotherapy

After successful anesthesia, the patient underwent TURBT. Other methods such as laser resection could also be used. The tumor should be completely removed and biopsy specimens taken as much as possible. Then, under the direct vision of the electrocautery scope, cryoablation was performed on the base of the tumor lesion. The freezing area was single lesion and at least 2 freezing cycles were carried out (the freezing start to the rewarming end constituted one cycle), with each cycle lasting 3-5 minutes. If the lesion area was large, 2 more freezing cycles could be added at different positions of the lesion to ensure coverage of the lesion area. After the operation, based on the pathological and immunohistochemical results, adjuvant immunotherapy was initiated, and concurrent adjuvant rhythm chemotherapy was also combined.

PROCEDURE

The conventional surgery treatment group

According to the guidelines, a radical cystectomy should be performed, and at the same time, a urinary diversion procedure should be carried out based on the specific situation, such as bladder channeling, ileal bladder substitution, ureterocutaneous fistula, in situ neobladder surgery, etc. (open, laparoscopic or robot-assisted methods are all acceptable). The biopsy and resected specimens should be sent for pathological examination. The postoperative adjuvant treatment plan is determined by the attending physician based on the patient's condition as appropriate.

Trial Locations (1)

200433

RECRUITING

ChangHai Hospital, Shanghai

All Listed Sponsors
lead

Changhai Hospital

OTHER

NCT07204132 - Investigation Into the Integration of Intracavitary Cryoablation and Immunotherapy in Bladder-Preserving Therapy | Biotech Hunter | Biotech Hunter