Bladder cancer
Conditions
Interventions
HER2-positive group:RC-48 combined with BCG perfusion and Tislelizumab
HER2-negative group:Internal iliac artery perfusion combined with BCG perfusion and Tislelizumab
Sponsors
The First Affiliated Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1 Fully understand this study and voluntarily sign the informed consent form, with good compliance and cooperation in follow-up visits. 2 Age is 18 years or older, with no gender restrictions. 3 ECOG performance status score is 0 or 1. 4 Clinically diagnosed with multiple bladder urothelial carcinoma at stages cTa to cT1, and a pelvic MRI has been completed to define the extent of the lesion before cystoscopy. 5 The pathology is urothelial carcinoma, and it is determined to be high-risk or very high-risk non-muscle invasive bladder cancer according to the EAU/NCCN guidelines for the diagnosis and treatment of bladder cancer. There should be results from Her2 immunohistochemical staining. 6 Expected life expectancy is more than 3 months. 7 Relevant laboratory tests are conducted within 14 days before entering treatment, and the laboratory tests must meet the following criteria: Complete blood count (without blood transfusion, G-CSF use, or drug correction within 14 days before the test): (1) Hb>=90g/L; (2) ANC>=5×10^9/L; (3) PLT>=80×10^9/L; Biochemical tests (without albumin transfusion within 14 days before the test): (1) TBIL=30mL/min.
Exclusion criteria
Exclusion criteria: 1 Patients with any active, known, or suspected autoimmune diseases. Enrollment of patients who are in a stable condition and do not require systemic treatment with immunosuppressants is allowed. 2 Patients who require systemic treatment with corticosteroids or other immunosuppressants within 14 days prior to drug administration. 3 Patients who have received HER2-targeted therapy, immunotherapy, or chemotherapy within 6 months prior to meeting all the inclusion criteria of this study. 4 Patients who have previously been treated with anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, or anti-CTLA-4 antibodies (or any other antibodies that act on T-cell co-stimulation or checkpoint pathways). 5 Patients who have experienced any of the following symptoms within 6 months prior to drug administration: myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident, or pulmonary embolism. 6 Patients who are highly suspected of having interstitial pneumonia; or patients who may interfere with the detection or management of suspected drug-related pulmonary toxicity. 7 Other active malignant tumors requiring concurrent treatment, including upper urinary tract urothelial carcinoma. 8 Patients who have received live attenuated vaccines within 4 weeks prior to enrollment or plan to receive them during the study period. 9 Patients with a known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 10 Patients with active tuberculosis must be excluded. Patients suspected of having active tuberculosis must be examined by chest X-ray, sputum, and ruled out through clinical symptoms and signs. Patients with a history of active tuberculosis infection within the last year, even if treated, must be excluded; patients with a history of active tuberculosis infection more than a year ago must also be excluded, unless it is proven that all previous anti-tuberculosis treatments were appropriately administered. 11 Patients who have been excluded from any clinical trial of anti-PD-1 or anti-PD-L1 antibodies due to a negative PD-L1 status. 12 Patients with a known history of positive HIV tests or known acquired immunodeficiency syndrome. 13 Untreated active hepatitis (hepatitis B: positive for HBsAg and HBV DNA = 500 IU/mL; hepatitis C: positive for HCV RNA and abnormal liver function); co-infection with hepatitis B and C. 14 Patients with peripheral neuropathy of grade >= 2. 15 Patients known to be allergic to components of PD-1 monoclonal antibody/ cisplatin/ epirubicin/ BCG vaccine/ videnceptin. 16 Patients who have had severe allergic reactions to other monoclonal antibodies. 17 Patients who have had allergies or intolerance to infusions. 18 As judged by the investigator, patients have other factors that may lead to the premature termination of this study, such as other diseases, severe laboratory abnormalities, or family or social factors that may affect patient safety, or the collection of study data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year recurrence-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bladder preservation rate;Adverse reactions; | — |
Countries
China
Contacts
Public ContactJunxing Chen
The First Affiliated Hospital, Sun Yat-sen University
Outcome results
None listed