bladder cancer
Conditions
Interventions
experimental group :Intravesical Instillation of Disitamab Vedotin,Administered once a week for a total of six weeks.
Sponsors
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Must voluntarily agree to participate in the study and sign the informed consent form. 2. Must be male or female, aged between 18-75 (inclusive). 3. Must have a disease that meets the following criteria: the subject's NMIBC risk group is classified as high-risk (including the very high-risk group), according to the "Guidelines for the Diagnosis and Treatment of Bladder Cancer in China (2022)". Subjects must also have urothelial cancer, have completed TURBT within 3 weeks prior to the study administration with all visible lesions resected, and clinical stage (cTa/T1±CIS, N0, M0) with no distant metastasis confirmed by imaging evaluation within 3 months prior to enrollment. 4. Previous BCG treatment must meet one of the following conditions: a) High-risk NMIBC patients who have not received previous BCG treatment, due to personal or medical reasons, including refusal of BCG treatment, contraindications to BCG treatment, or lack of access to BCG. b) High-risk NMIBC patients who are non-responsive to BCG, with either persistent/recurrent high-risk NMIBC within 12 months (±1 month) after sufficient BCG treatment or high-grade T1 disease after induction BCG treatment. Note: Adequate BCG therapy is defined as at least 5 bladder infusions of BCG within 2 months, followed by at least 2 bladder infusions of BCG within any consecutive 6-week period within 10 months (i.e., at least "5+2" bladder infusions of BCG). 5. Must be unsuitable for radical bladder cancer surgery or have refused such surgery, as evaluated by urologists. 6. Tumor tissue samples obtained from the subject via TURBT within 3 weeks should demonstrate HER2 expression of 1+, 2+, or 3+ upon immunohistochemistry (IHC) testing. 7. Must have an ECOG performance status of 0-2. 8. Must have adequate cardiac, bone marrow, liver, and renal functions, meeting the following criteria within 7 days prior to study administration (normal values are determined by the clinical trial center): • Left ventricular ejection fraction = 50% • Hemoglobin =9g/dL • Absolute neutrophil count (ANC) =1.5×109/L • Platelets = 100×109/L • Serum total bilirubin = 1.5 times the upper limit of normal (ULN) • ALT and AST=2.5×ULN • Serum creatinine =1.5×ULN or calculated creatinine clearance (CrCl) =50mL/min according to the Cockcroft-Gault formula 9. Female subjects should be surgically sterilized, postmenopausal, or agree to use at least one medically approved contraceptive method (such as intrauterine device, contraceptive pills, or condoms). Blood pregnancy test must be negative within 7 days prior to study enrollment, false positive results can be ruled out by the investigator. Male subjects should agree to use at least one medically approved contraceptive method during the study treatment period and for 6 months after the end of the study treatment period. 10. Must be willing and able to comply with trial and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Individuals with muscle-invasive bladder cancer (T2 and above) and/or those with regional lymph node involvement or distant metastasis. 2. Cases with coexisting extravesical (i.e., urethra, ureter, or renal pelvis) urothelial carcinoma. 3. Individuals who have received any other anti-cancer therapy within 4 weeks prior to the study administration, including but not limited to chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc., excluding one infusion chemotherapy immediately completed after TURBT. 4. Individuals who have not recovered from adverse events caused by previously used antineoplastic drugs to a CECAT 5.0 grade of 0-1 within 2 weeks prior to study commencement. 5. Those who plan to undergo major surgery within 4 weeks before the study administration or during the trial. 6. Serum virology examination results (based on the research center's normal value): - Positive for HBsAg or HBcAb, and a positive HBVDNA copy number; - Positive for HCVAb and a positive HCV RNA test result; - Positive HIVAb test result. 7. Individuals who have received live vaccines within 4 weeks prior to study administration or who plan to receive any vaccines during the study period (excluding the inactivated SARS-CoV-2 vaccines). 8. Heart failure of NYHA grade 3 or above. 9. Serious arterial/venous thrombotic events or cardiovascular and cerebrovascular accidents within 6 months prior to study administration, such as deep vein thrombosis, pulmonary embolism, cerebral infarction, cerebral hemorrhage, myocardial infarction, etc. Excludes asymptomatic lacunar infarctions not requiring clinical intervention. 10. Active or advanced infections requiring systemic treatment, such as active tuberculosis. 11. Active, uncontrolled systemic diseases or serious comorbidities, as assessed by the investigator, including diabetes, hypertension, liver cirrhosis, interstitial pneumonia, obstructive pulmonary disease, etc. 12. Individuals with any other diseases, metabolic abnormalities, physical examination abnormalities or laboratory test abnormalities that, in the investigator's judgment, may suggest the presence of a condition unsuitable for the use of the study drug, could affect the interpretation of study results, or could put the patient at high risk. 13. Active autoimmune diseases requiring systemic treatment (such as immunomodulators, corticosteroids, or immunosuppressants) within 6 months prior to study administration. Exception applies to alternative treatments (e.g., thyroxine for adrenal or pituitary insufficiency, or physiologic corticosteroid replacement therapy). 14. Patients with other malignant tumors within 5 years prior to study commencement, except: - Malignant tumors expected to be curable with treatment (including but not limited to adequately treated thyroid cancer, carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with radical surgery). - Men with prostate cancer who have previously received specific treatments (surgery or radiation): a) T2N0M0 or earlier stage; b) Gleason score =7 and prostate-specific antigen (PSA) undetectable for at least 1 year after anti-androgen therapy; c) Patient's condition is stable for 1 year prior to study enrollment, either due to active monitoring without specific treatment or after receiving specific treatment. 15. History of allogeneic hematopoietic stem cell transplantation or organ tra
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity;Incidence of Adverse Events (AEs); | — |
Countries
China
Contacts
Public ContactLin TianXin
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Outcome results
None listed