Clinical Application of a Novel Endoscopic Cryoablation Technique Combined With Immunotherapy (TECIC Model) in Bladder-Preserving Therapy for Bladder Cancer

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Professional Translation: This study is a single-center, prospective, non-randomized, parallel-controlled clinical trial initiated and conducted by the Department of Urology at the First Affiliated Hospital of Naval Medical University. The Principal Investigator is Professor Zhang Zhensheng, and the projected execution period for the project is from July 2025 to July 2027. The study aims to evaluate the efficacy and safety of an innovative integrated bladder-preserving treatment model-novel endoluminal precise cryoablation combined with Transurethral Resection of Bladder Tumor (TURBT), immunotherapy, and metronomic chemotherapy (the TECIC model)-in patients with high-risk non-muscle-invasive bladder cancer (NMIBC). Bladder cancer is a common malignant tumor of the urinary system. While radical cystectomy remains the standard therapy, it is associated with significant trauma, numerous complications, and substantially impacts patient quality of life. Existing bladder-preservation strategies, such as TURBT alone or trimodal therapy (chemoradiation), face challenges including high recurrence rates and variable efficacy. This research builds upon prior development and clinical exploration of a domestically developed novel endoluminal liquid nitrogen balloon cryoablation technology. This technology enables precise cryoablation of the tumor base under direct endoscopic vision, inducing immunogenic cell death, which theoretically can synergize with immunotherapy and chemotherapy, offering a new approach to bladder-preserving treatment. The study plans to enroll 180 patients diagnosed with high-risk NMIBC via biopsy or TURBT. Patient preference will be a key factor in group assignment. The experimental group (n=90) will undergo TURBT combined with intraoperative endoluminal precise cryoablation (at least 2 freeze-thaw cycles per lesion, each cycle lasting 3-5 minutes), followed by adjuvant anti-PD-1 monoclonal antibody immunotherapy (e.g., Camrelizumab, Tislelizumab, etc., for at least 3-6 cycles) and metronomic chemotherapy with a Gemcitabine plus Cisplatin (GC) regimen (at least 4-6 cycles). The control group (n=90) will receive radical cystectomy and urinary diversion selected according to current guidelines and individual circumstances; postoperative adjuvant therapy will be at the discretion of the attending physician. The primary efficacy endpoint of the study is 5-year Overall Survival (OS). Secondary efficacy endpoints include the rate of local intravesical recurrence/progression, 1-year and 2-year OS, 1-year, 2-year, and 5-year Progression-Free Survival (PFS), as well as quality of life scores. The safety endpoint is the incidence of postoperative adverse events. Furthermore, the study will explore biomarkers such as changes in local immune infiltration (assessed by detecting multiple immune markers in biopsy tissue) and peripheral blood cytokine levels and immune cell function before and after treatment. Statistical analysis will employ the Full Analysis Set (FAS), the Per Protocol Set (PPS), and a 1:1 propensity score matching analysis set to reduce selection bias. Analysis of the primary efficacy index will be conducted at a one-sided significance level of 0.025. In contrast, other indexes will use a two-sided significance level of 0.05, utilizing SAS 9.3 statistical software. Descriptive analysis, efficacy analysis, and safety analysis will be performed separately. This study will strictly adhere to the principles of the Declaration of Helsinki, relevant Chinese regulations, and Good Clinical Practice (GCP). The protocol has been submitted for review and approval by the Institutional Review Board (IRB)/Ethics Committee. All enrolled patients are required to provide written informed consent before participation. It is anticipated that this study will provide a new, effective, and minimally invasive treatment option that preserves bladder function and quality of life for patients with high-risk NMIBC, while also preliminarily investigating the mechanism of action of the TECIC model.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Age between 18 and 85 years old, gender not restricted;

• Clinically diagnosed as patients with bladder tumors, and classified as high-risk non-muscle-invasive bladder cancer through biopsy or TURBT staging.

• \* High-risk non-muscle bladder cancer is defined as meeting any of the following criteria: ① T1 stage tumor; ② High-grade urothelial carcinoma; ③ Simultaneously meeting: multiple, recurrent and diameter \> 3cm bladder cancer;

• The number of tumors is no more than 5;

• Have the intention to preserve the bladder;

• Voluntarily sign the informed consent form and be able to cooperate throughout the trial.

Locations
Other Locations
China
ChangHai Hospital
RECRUITING
Shanghai
Contact Information
Primary
Shuxiong Zeng
zengshuxiong@126.com
86-18930568759
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 180
Treatments
Experimental: Based on patient preference, eligible subjects were assigned to the experimental group, which involv
After successful administration of anesthesia, a transurethral resection cystoscope is used to perform transurethral bladder tumor resection (TURBT). Alternative methods such as laser resection can also be employed to remove the tumor as thoroughly as possible and obtain biopsy samples. Under the direct visualization of the resection scope, cryoablation is performed at the base of the tumor lesion. For a single lesion, at least two complete freezing-thawing cycles (defined as the freezing start of each cycle to the complete thawing end) are applied; the freezing duration of each cycle is 3 to 5 minutes. If the lesion is large, two additional freezing-thawing cycles can be applied in different areas of the lesion to ensure adequate coverage of the entire lesion area. Postoperatively, based on the pathological and immunohistochemical results, adjuvant immunotherapy is initiated.
Other: control group
According to the guidelines, a radical cystectomy should be performed. At the same time, according to the specific situation, urinary diversion procedures such as bladder channeling, ileal bladder substitution, ureterocutaneous fistula, and in situ neobladder surgery (open, laparoscopic or robot-assisted) can be carried out. 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.
Related Therapeutic Areas
Sponsors
Leads: Changhai Hospital

This content was sourced from clinicaltrials.gov