bladder cancer
Conditions
Interventions
Experimental group:adebrelimab combined with sacituzumab tirumotecan
Sponsors
Tangdu Hospital, Air Force Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. be male or female, >=18 years of age, and older patients (>75 years of age) may be admitted to the study at the investigator's discretion. 2. understand the study and possible risks and agree to sign an informed consent form. 3. have a histologically confirmed diagnosis of operable non-metastatic muscle invasive bladder cancer (stage T2-T4N0M0 MIBC, excluding renal pelvis, ureters, and urethra) as assessed by CT + PET/CT + pelvic MRI. 4. Patients scheduled to undergo radical cystectomy. 5. ECOG score 0-1. 6. patients with relatively good renal function GFR = 45 ml/min who can tolerate medication and surgery. 7. Refusal or unsuitability for standard radiotherapy regimens. 8. normal major organ function, including: 1. routine blood tests (no blood components, cell growth factors, leukocyte boosters, platelet boosters, or anaemia-correcting drugs are permitted within 14 days prior to the first use of the study drug): neutrophil count >= 1.5 x 10^9/L; platelet count >= 100 x 10^9/L; haemoglobin >= 90g/L; 2. Blood biochemistry: total bilirubin = 50mL/min; 3. Coagulation: International Normalised Ratio (INR) <= 1.5 x ULN; Activated Partial Thromboplastin Time (APTT) <= 1.5 x ULN. 9. Female subjects of childbearing potential are required to have a negative serum pregnancy test within 72 hours prior to initiation of study drug administration and to use effective contraception (e.g., intrauterine device (IUD), birth control pills, or condoms) during the trial period and for at least 3 months after the last dose; for male subjects whose partner is a female of childbearing potential, they should be surgically sterilised or agree to use effective contraception (e.g., IUD, pill, or condom) during the trial period and for at least 3 months after the last dose. Subjects should be surgically sterilised or agree to use effective contraception during the trial and for 3 months after the last dose. 10. Subjects are compliant and co-operate with follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Known allergy or hypersensitivity to any component of the study drugs. 2. Patients with neuroendocrine histological features will be excluded. 3. Refusal to undergo radical cystectomy (RC). 4. Prior or concurrent treatment with any of the following: 1. Any prior radiotherapy, chemotherapy, or other anti-tumor drugs for the current malignancy. 2. Use of immunosuppressive medication or systemic corticosteroid therapy (>10 mg daily prednisone or equivalent) for immunosuppressive purposes within 2 weeks prior to the first dose of the study drug. Inhaled or topical steroids and physiologic replacement doses of corticosteroids (>10 mg daily prednisone equivalent) for non-active autoimmune conditions are permitted. 3. Administration of a live attenuated vaccine within 4 weeks prior to the first dose. 4. Major surgical procedure or significant traumatic injury within 4 weeks prior to the first dose. 5. Presence of any active autoimmune disease or a history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be eligible if well-controlled with hormone replacement therapy). Patients with psoriasis or childhood asthma/allergies that have resolved completely in adulthood without intervention may be eligible; however, patients requiring medical intervention with bronchodilators are not eligible. 6. History of immunodeficiency, including a positive HIV test result, other acquired or congenital immunodeficiency disorders, or history of organ transplantation or allogeneic bone marrow transplantation. 7. Poorly controlled cardiac clinical symptoms or diseases, including but not limited to: 1. heart failure of New York Heart Association (NYHA) Class II or higher; 2. unstable angina pectoris; 3. myocardial infarction within 1 year; 4. clinically significant supraventricular or ventricular arrhythmia that is untreated or remains poorly controlled despite intervention. 8. Serious active infection (CTCAE > grade 2) within 4 weeks prior to the first dose (e.g., severe pneumonia requiring hospitalization, bacteremia, infectious complications). Evidence of active pulmonary inflammation on baseline chest imaging, or signs/symptoms of infection within 14 days prior to the first dose requiring oral or intravenous antibiotic therapy (excluding prophylactic antibiotic use). 9. Active pulmonary tuberculosis (TB) infection identified via medical history or CT scan, or a history of active TB infection within 1 year prior to enrollment, or a history of active TB infection more than 1 year ago without appropriate treatment. 10. Active hepatitis B (HBV DNA >= 2000 IU/mL or 104 copies/mL) or active hepatitis C (positive HCV antibody with HCV RNA above the lower limit of detection of the assay). 11. Diagnosis of another malignancy within 5 years prior to the first dose, except for malignancies with a low risk of metastasis or death (5-year survival rate > 90%), such as adequately treated basal cell or squamous cell skin carcinoma, or carcinoma in situ of the cervix, which may be considered for enrollment. 12. Women who are pregnant or breastfeeding. 13. Any other condition, in the investigator's judgment, that may lead to premature termination of the study, such as co-existing severe illness (including psychiatric disorders) requiring treatment, alcohol or drug abuse, familial or social factors, or other issues likely to co
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical complete response (cCR) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-free survival (EFS) rate;Bladder-Intact event-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactWei Zhang
Tangdu Hospital, Air Force Military Medical University
Outcome results
None listed