Bladder urothelial carcinoma
Conditions
Interventions
Experimental group:After undergoing maximum transurethral bladder tumor resection (cTURBT), the subjects received treatment with Disitamab Vedotin combined with toripalimab for 6 cycles (12 weeks), fo
Comprehensive treatment (not limited to chemotherapy, radiotherapy, immunotherapy, targeted treatment, surgical treatment, etc., if necessary, MDT discussion) or salvage bladder cancer radical surgery
After 24 weeks of re-evaluation of the therapeutic effect, if cCR is achieved, the patient will receive 1-year bladder conserving treatment with toripalimab immune maintenance treatment. The endpoint
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: (1) Voluntarily participate in this experiment, be able to sign a written informed consent form, and understand and agree to comply with the requirements and evaluation schedule of this study. (2) A male or female who is over 18 years old on the date of signing the informed consent form. (3) If it is a patient with cT2-T4aN0M0 bladder urothelial carcinoma diagnosed histologically or assessed imageologically based on the TNM staging of bladder cancer (AJCC 8th Edition) after TURBT surgery, the researcher believes that there are residual lesions; Among them, all patients must have histopathological evidence of intrinsic muscle layer infiltration. Patients with mixed type tumors in histology and pathology are required to have urothelial carcinoma as the dominant factor (at least 50%). (4) After evaluation by the researchers, they refused to undergo radical cystectomy. (5) HER2 detection was performed on tumor samples before treatment in a local laboratory: HER2 expression was confirmed to be = 2+after IHC results. (6) ECOG status 0-1. (7) The patient's organ function is good, as measured by the following screening period test values (obtained = 14 days before enrollment): a. When screening the following items, patients are not allowed to use growth factor support for = 14 days before sample collection; i. Neutrophil absolute count = 1.5 ×10^9/L; Ii. Platelets = 100 ×10^9/L; Iii. Hemoglobin = 90g/L; b. International standardized ratio or activated partial thromboplastin time = 1.5 upper limit of normal value (ULN); c. Total serum bilirubin = 1.5 × ULN; d. AST, ALT, and alkaline phosphatase = 2.5 × ULN; e. The calculated creatinine clearance rate is greater than 30 mL/min; f. Left ventricular ejection fraction (LVEF) = 50%; (8) Women with fertility must be willing to take efficient contraception measures during the study period, and within = 180 days after the last dose of Disitamab Vedotin or toripalimab (whichever occurs later), and have a negative urine or serum pregnancy test result within = 7 days before enrollment. (9) Uninservated males must be willing to take efficient contraceptive measures during the study period and within = 180 days after the last dose of either Disitamab Vedotin or toripalimab (whichever occurs later). (10) The expected lifespan exceeds 12 months. (11) Willing and able to follow the research and follow-up procedures.
Exclusion criteria
Exclusion criteria: (1) Previously received therapies targeting PD-1, PD-L1, PD-L2, CTLA4, Her2, or other antibodies or drugs specifically targeting T cell co stimulation or checkpoint channels. (2) Within 28 days prior to enrollment, receive other approved systemic anti-cancer treatments or systemic immune modulators (including but not limited to interferon, interleukin-2, and tumor necrosis factor). (3) Previous radiotherapy for bladder cancer. (4) Previously received drug therapy for tumors (such as chemotherapy), except for local intravesical chemotherapy or immunotherapy, which should be completed at least 2 weeks before the start of bladder conserving drug therapy in the study. (5) Within 28 days prior to enrollment, major surgery or major trauma occurred (implantation of vascular access devices and TURBT are not considered major surgeries). (6) Severe infections requiring systemic antibacterial, antifungal, or antiviral treatment within 14 days prior to enrollment (HBV infection shall be treated according to exclusion criteria 12). (7) Received a live vaccine within 28 days prior to enrollment (seasonal influenza vaccines are usually inactivated vaccines and therefore allowed to be used. Intranasal vaccines are considered live vaccines and therefore not allowed to be used). (8) Have received any Chinese herbal medicine or traditional Chinese patent medicines and simple preparations for cancer control within 14 days before enrollment. (9) Active autoimmune diseases that require systemic treatment are evaluated by researchers as having an impact on the research treatment. (10) Long term and extensive use of hormones or other immunosuppressive agents are required, which researchers have assessed as having an impact on the study and treatment. (11) History of potassium, sodium, calcium abnormalities or hypoalbuminemia, interstitial lung disease, noninfectious pneumonia, uncontrolled tuberculosis, neuropathy (peripheral neuropathy, central nerve damage, etc.), psychosis or other uncontrolled systemic diseases, including diabetes, hypertension Cardiovascular diseases (such as active heart disease within the 6 months prior to enrollment, including severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, and ventricular arrhythmias requiring medication treatment), etc. (12) Untreated chronic hepatitis B subjects or carriers of hepatitis B virus (HBV) with HBV DNA = 500 IU/mL (2500 copies/mL) are not allowed to enter the study. Note: Patients with inactive hepatitis B surface antigen carriers or stable active HBV infection (HBV DNA<500IU/mL [2500 copies/mL]) after continuous antiviral treatment can be enrolled. HBV DNA testing is only performed in patients with positive antibodies against hepatitis B surface antigen. (13) Patients with active hepatitis C are not eligible for enrollment. Patients who tested negative for HCV antibodies during the screening period, or those who tested positive for HCV antibodies and tested negative for HCV RNA, can be enrolled. Only patients who test positive for HCV antibodies need to undergo HCV RNA testing. (14) Have a history of immunodeficiency (including positive HIV testing for human immunodeficiency virus, other acquired or congenital immunodeficiency diseases) or a history of allogeneic stem cell transplantation or organ transplantation. (15) Known to be allergic to any investigational drug or excipient or other monoclonal antibody. (16) Pregnant or lactating women. (17) Simultaneously parti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year disease-free survival rate of intact bladder; | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-year disease-free survival rate of intact bladder;Clinical remission rate;Over survival;5-year survival rate;quality of life;Treatment costs;Exploratory indicators;partial response rate;progressive disease rate; | — |
Countries
China
Contacts
Public ContactJian Huang
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed