An Exploratory Study of the Efficacy and Safety of SBRT Following Induction Therapy With Neoadjuvant Immunotherapy Combined With Chemotherapy in Muscle-Invasive Bladder Cancer

November 8, 2026 updated by: Tianjin Medical University Cancer Institute and Hospital

This study aims to systematically evaluate the efficacy and safety of this innovative comprehensive treatment model in patients with MIBC. By prospectively observing the clinical complete remission rate, bladder recurrence-free survival period, overall survival period, as well as the incidence and severity of treatment-related adverse events, investigators hope to clarify the clinical effectiveness of this model and provide a potential new and efficient bladder-preserving approach for MIBC. Comprehensive assessment of its safety profile will provide a basis for patient management and risk control in clinical practice. Exploration of potential biomarkers (such as PD-L1 expression, tumor mutation burden, etc.) is expected to enable precise selection of treatment options in the future. The successful implementation of this study is expected to bring significant changes to the treatment paradigm for MIBC, achieving the best oncological outcomes while maximizing the preservation of patient organ function and quality of life, and having significant social benefits and clinical promotion value.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Those who voluntarily sign the informed consent form, understand the nature, purpose and procedures of this trial and voluntarily comply with the trial requirements;
  • Male or female, aged between 18 and 85 years;
  • Patients with pathologically confirmed MIBC;
  • Those who meet the new adjuvant treatment criteria for MIBC and have not undergone tumor-related treatment before;
  • Patients with clinical tumor stage of cT2-T4aN0M0;
  • Male participants or potentially pregnant females must use highly fertile males or potentially pregnant females during the trial, must use highly effective contraceptive methods (such as oral contraceptives, intrauterine devices, inhibitory methods or contraceptive methods combined with spermicides) during the test, must use contraceptive methods combined with spermicides at the end of the treatment, and use contraception for 12 months after the treatment;
  • The main organ functions simultaneously meet the following standards: 1) Absolute neutrophil count ≥ 1.5 × 109/L; 2) Platelets ≥ 90 × 109/L; 3) Hemoglobin ≥ 90 g/L; 4) Serum creatinine ≤ 1.5 times the upper limit of normal (ULN); 5) Serum total bilirubin ≤ 1.5 times ULN (except for those with Gilbert syndrome); 6) Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 1.5 times ULN; 7) International normalized ratio (INR), activated partial thromboplastin time (APTT) ≤ 1.5 times ULN.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
  • People who have the intention to preserve their bladder.

Exclusion Criteria:

  • Pregnant or lactating women, as well as women who wish to conceive (pelvic radiotherapy may cause premature aging of the ovaries);
  • Patients with stage IV bladder cancer with distant metastasis;
  • Those with a history of primary malignant tumors in other parts;
  • Those with severe organ dysfunction, such as recent cerebrovascular disease, or with diseases or factors that can cause cerebral edema or intracranial hypertension; severe heart diseases or discomfort, including but not limited to the following diseases/factors: 1) Currently suffering from untreated or uncontrollable hypertension (systolic pressure > 180 mmHg and/or diastolic pressure > 100 mmHg) or unstable angina pectoris; 2) According to the New York Heart Association (NYHA) classification standard, currently having a history of any level of congestive heart failure or severe need for treatment of arrhythmia (except for atrial fibrillation or paroxysmal supraventricular tachycardia); 3) History of myocardial infarction within the previous 6 months; 4) Patients with pacemakers; significantly reduced liver function or liver reserve function, active liver disease; severe renal parenchymal or renal vascular lesions, renal insufficiency; severe respiratory dysfunction; uncorrected moderate-to-severe anemia; obvious bleeding tendency or DIC tendency;
  • Subjects with a known history of mental illness, poor compliance;
  • Those who cannot tolerate neoadjuvant chemotherapy or immunotherapy, radiotherapy;
  • Women of childbearing age, who do not agree to take one or more effective contraceptive measures during the treatment period and at least 6 months after the last study treatment; with a positive blood pregnancy test;
  • Those considered by the investigators to be unsuitable for enrollment or may not be able to complete this trial for other reasons;
  • Other situations that the review personnel from the registration study consider to be unqualified based on the registration: such as potential situations inconsistent with the clinical protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group

Maximal TURBT; Induction therapy: Suliimab combined with gemcitabine and cisplatin/oral carboplatin, for a total of 2 cycles; Concurrent chemoradiotherapy (after completing 2 cycles of induction therapy); One course of SBRT radiotherapy: 25Gy/5Gy/5f for the tumor area/tumor bed of the primary bladder lesion; Two courses of external beam radiotherapy: Bladder radiotherapy (45Gy/1.8Gy/25F); Cystoscopy TURBT; Maintenance therapy.
Drug: Suruilimab immunotherapy

Test Drug: Suliimun Antibody Injection

1. Drug Introduction and Special Mechanism Generic Name: Suliimun Antibody Injection Trade Name: Hanszhuang® Category: Recombinant Anti-PD-1 Humanized Monoclonal Antibody Special Mechanism: Suliimun is an immune checkpoint inhibitor. PD-1, as a cell surface receptor, is an important immunosuppressive molecule that regulates T cell function. PD-L1 (and other) ligands are expressed on antigen-presenting cells, tumor cells, or other cells in the tumor microenvironment. The binding of PD-1 to PD-L1 can inhibit T cell proliferation and the secretion of related cytokines. This product is a new injectable recombinant humanized anti-PD-1 monoclonal antibody. By blocking the binding of PD-1 to PD-L1, it enhances the immune response of T cells against tumors, thereby exerting anti-tumor effects.

Role in This Study: In this trial, Suliimun was used as the core component of neoadjuvant immunotherapy, combined with gemcitabine and cisplatin chemotherapy, aimin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical complete remission (cCR)
Time Frame: 3year

1) The bladder biopsy (including all visible abnormal areas and any additional TURBT or biopsy performed for known muscle-invasive cancer lesions before neoadjuvant therapy) did not reveal any high-grade malignant tumors (i.e., no pTa/pT1/pTis); 2) The urine cytology examination did not detect any malignant cells; 3) The cross-sectional imaging examination provided no clear evidence of local or metastatic diseases.
3year
Bladder event-free survival (BI-EFS)
Time Frame: 3year

It is defined as the time period from the initiation of the treatment plan to the recurrence of muscle-invasive bladder cancer (MIBC), regional pelvic recurrence, distant metastasis, bladder cancer-related death, or bladder resection.
3year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Relapse-free survival (RFS)
Time Frame: 3year
3year
cancer-specific survival (CSS)
Time Frame: 3year
3year
disease-free survival (DFS)
Time Frame: 3year
3year
overall survival (OS)
Time Frame: 3year
3year
bladder preservation rate
Time Frame: 3year
3year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tianjin Medical University Cancer Institute and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E20261405

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The individual participant data (IPD) will not be shared to protect the confidentiality of the patients, and in accordance with the institutional data protection policy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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