Bladder CancerNCT07204132
Investigation Into the Integration of Intracavitary Cryoablation and Immunotherapy in Bladder-Preserving Therapy
A study testing TURBT combined with cryoablation-assisted postoperative immunotherapy and The conventional surgery treatment group in people with Bladder Cancer, run by Changhai Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- TURBT combined with cryoablation-assisted postoperative immunotherapy and The conventional surgery treatment group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Preoperative imaging indicated involvement of organs around the bladder (such as ureters, prostate, rectum, etc.), the pelvic or abdominal wall, or lymph node metastasis (N1) and distant metastasis (M1) stage;
- Preoperative imaging indicated hydronephrosis, pathology suggested carcinoma in situ or diagnostic TURBT indicated diffuse tumor growth during the procedure;
- Known to be allergic to chemotherapy drugs and/or immunotherapy drugs;
- Complicated with severe infectious diseases such as bacteremia and toxemia;
- Complicated with severe coagulation dysfunction;
- Suffering from serious diseases such as heart, brain, lung, liver, kidney, etc., and unable to tolerate surgery;
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- Suffering from other malignant tumors;
- Pregnant or lactating women;
- Complicated with severe complications such as urethral stenosis that cannot tolerate cystoscopy surgery;
- Complicated with prohibited medications, including systemic anti-tumor drugs and immunosuppressants;
- Participating in other clinical trials simultaneously;
- Other situations that the investigator considers inappropriate for participating in this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
ChangHai Hospital
Shanghai, Shanghai Municipality, 200433
About this study
Official title: Clinical Application of a Novel Endoscopic Cryoablation Technique Combined With Immunotherapy (TECIC Model) in Bladder-Preserving Therapy for Bladder Cancer
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.
Read more
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.
- Conditions
- Bladder Cancer
- Being tested
- TURBT combined with cryoablation-assisted postoperative immunotherapy, The conventional surgery treatment group
- Keywords
- TECIC Model, Immunotherapy, Endoscopic Cryoablation Technique
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TURBT combined with cryoablation-assisted postoperative immunotherapyProcedure or surgery
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.
The conventional surgery treatment groupProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Based on patient preference, eligible subjects were assigned to the experimental group, which involv | Experimental | 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. Receives: Procedure: TURBT combined with cryoablation-assisted postoperative immunotherapy |
| control group | Other | 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. Receives: Procedure: The conventional surgery treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Five-year overall survival, OS
Measured: 24 months
Secondary outcomes (1)
Local recurrence/progression rate within the bladder cavity
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Sep 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuxiong Zeng, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204132
- Sponsor's protocol ID
- KTSB20250312016
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared publicly to ensure patient confidentiality and privacy, as the informed consent obtained from participants did not include provisions for public data sharing. Additionally, data sharing is restricted by institutional policies and national regulations governing personal information protection.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of a Novel Endoscopic Cryoablation Technique Combined With Immunotherapy (TECIC Model) in Bladder-Preserving Therapy for Bladder Cancer
- ClinicalTrials.gov ID
- NCT07204132
- Acronym / sponsor ID
- KTSB20250312016
- Conditions
- Bladder Cancer
- Keywords
- TECIC Model, Immunotherapy, Endoscopic Cryoablation Technique
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Based on patient preference, eligible subjects were assigned to the experimental group, which involv | Experimental | Procedure: TURBT combined with cryoablation-assisted postoperative immunotherapyAfter 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. |
| control group | Other | Procedure: The conventional surgery treatment groupAccording 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- 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.
Key exclusion criteria (12 listed)
- Preoperative imaging indicated involvement of organs around the bladder (such as ureters, prostate, rectum, etc.), the pelvic or abdominal wall, or lymph node metastasis (N1) and distant metastasis (M1) stage;
- Preoperative imaging indicated hydronephrosis, pathology suggested carcinoma in situ or diagnostic TURBT indicated diffuse tumor growth during the procedure;
- Known to be allergic to chemotherapy drugs and/or immunotherapy drugs;
- Complicated with severe infectious diseases such as bacteremia and toxemia;
- Complicated with severe coagulation dysfunction;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TURBT combined with cryoablation-assisted postoperative immunotherapyAfter 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 or surgery | Based on patient preference, eligible subjects were assigned to the experimental group, which involv |
| The conventional surgery treatment groupAccording 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. | Procedure or surgery | control group |
Primary outcome
Five-year overall survival, OS
Time frame: 24 months
1 secondary outcome
Local recurrence/progression rate within the bladder cavity
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared publicly to ensure patient confidentiality and privacy, as the informed consent obtained from participants did not include provisions for public data sharing. Additionally, data sharing is restricted by institutional policies and national regulations governing personal information protection.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TURBT combined with cryoablation-assisted postoperative immunotherapy and The conventional surgery treatment group in people with Bladder Cancer, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuxiong Zeng (86-18930568759, zengshuxiong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Five-year overall survival, OS (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.