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

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

18 years - 85 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

36 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (0)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

No locations are listed. Use the official study contact.

Study team and timeline

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Study start

Dec 1, 2026 Estimated

Primary completion

Dec 1, 2027 Estimated

Study completion

Dec 1, 2030 Estimated

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts