Bladder Cancer
Conditions
Interventions
A:a) Tislelizumab: Administered on Day 1 of each cycle at a dose of 200mg per infusion, intravenously, once every three weeks.
b) Disitamab Vedotin: Administered on Day 2 of each cycle at a dose of 12
Sponsors
Second Hospital of Tianjin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1) Men and women aged 18 and above. 2) Histologically confirmed non-muscle invasive bladder carcinoma in situ, with or without papillary tumors. Patients who experience or recur with carcinoma in situ within 12 months after completing at least 7 BCG treatments. 3) Meet the criteria for BCG-unresponsive bladder carcinoma in situ: A full BCG treatment regimen should include at least 2 courses of BCG. The first course (induction) must include at least 5 of 6 treatments per week, and the second course may consist of either re-induction (at least 2 of 6 treatments) or maintenance (at least 2 of 3 treatments), with a schedule similar to the SWOG 8507 study protocol. 4) Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. 5) Willingness to provide tissue specimens for testing PD-L1 expression, tumor mutation burden, immunohistochemistry, DNA, and RNA testing. 6) Organ function levels must meet the following requirements: a. Hematologic parameters: Absolute neutrophil count = 1.5 × 10^9/L, platelet count = 80 × 10^9/L, hemoglobin = 6.0 g/dL (maintainable through symptomatic treatment). b. Liver function: Total bilirubin = 1.5 times the upper limit of normal, alanine aminotransferase, and aspartate aminotransferase = 2.5 times the upper limit of normal. 7) Subjects voluntarily entering the study, signing an informed consent form, demonstrating good compliance, and cooperating with follow-up.
Exclusion criteria
Exclusion criteria: 1) Non-urothelial carcinoma within the bladder. 2) Concomitant upper urinary tract urothelial carcinoma, tumors in other organs, and urethral tumors (excluding tumors such as those within the bladder wall at the ureteral orifice or invading the prostate part of the urethra). 3) Received or planned to receive attenuated live vaccines within 4 weeks prior to enrollment or during the study. 4) Active, known, or suspected autoimmune diseases. 5) Known history of primary immunodeficiency. 6) History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 7) Pregnant or lactating female patients. 8) Untreated active hepatitis B or hepatitis C infection. Patients receiving antiviral treatment will be assessed by the physician based on individual patient conditions to determine eligibility. 9) Use of immunosuppressive drugs within 4 weeks prior to the start of treatment, excluding nasal and inhaled corticosteroids or physiologic doses of systemic corticosteroids (i.e., not exceeding 10 mg/day of prednisone or equivalent corticosteroids). 10) Known or suspected allergy to Tislelizumab and Disitamab Vedotin. 11) Documented active tuberculosis. 12) Previous treatment with PD-1/PD-L1/CTLA-4 antibodies or other immunotherapies. 13) Currently participating in another clinical trial. 14) Reproductive-capable males or females at risk of pregnancy without adequate contraception. 15) Uncontrolled concurrent diseases, including but not limited to: a) HIV-infected individuals (HIV antibody positive). b) Severe active or poorly controlled severe infections. c) Evidence of severe or uncontrollable systemic diseases (such as severe mental, neurological disorders, epilepsy, or dementia, unstable or uncompensated respiratory, cardiovascular, liver, or kidney diseases, uncontrolled hypertension [defined as persisting at or above CTCAE Grade 2 despite medication]). d) Active bleeding or new-onset thrombotic diseases (except those that can be controlled by relevant symptomatic support therapy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cystectomy-Free Survival Time;Duration of Complete response;Progression-Free Survival;Overall survival; | — |
Countries
China
Contacts
Public ContactHu Hailong
Second Hospital of Tianjin Medical University
Outcome results
None listed