Bladder Cancer
Conditions
Interventions
Trial group:Vicriviroc 2mg/kg iv.drip (once every 2 weeks), Tislelizumab 200mg iv.drip (once every 3 weeks), combined with standard epirubicin instillation regimen (50mg per dose, once weekly for 8 we
Sponsors
The First Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patient has fully understood the study, voluntarily signed the informed consent form, demonstrates good compliance, and cooperates with follow-up visits; 2. Age >= 18 years, with no restriction on gender; 3. Eastern Cooperative Oncology Group (ECOG) performance status 3 months; 7. Relevant laboratory tests conducted within 14 days prior to treatment initiation must meet the following criteria: (1) Complete blood count (no blood transfusion, no use of G-CSF, and no medication for correction within 14 days prior to testing): 1) Hemoglobin (HB) >= 90 g/L; 2) Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; 3) Platelet count (PLT) >= 80 × 10^9/L. (2) Biochemical tests (no albumin infusion within 14 days prior to testing): 1) Total bilirubin (TBIL) = 30 mL/min.
Exclusion criteria
Exclusion criteria: 1.Patients with any active, known, or suspected autoimmune disease. Patients in a stable state who do not require systemic immunosuppressive therapy are permitted to be enrolled. 2.Patients requiring systemic treatment with corticosteroids or other immunosuppressive agents within 14 days prior to study drug administration. 3.Patients who have received HER2-targeted therapy, immunotherapy, or chemotherapy within 6 months prior to meeting all inclusion criteria for this study. 4.Previous treatment with anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, or anti-CTLA-4 antibodies (or any other antibody targeting T-cell co-stimulation or checkpoint pathways). 5.Occurrence of any of the following within 6 months prior to study drug administration: myocardial infarction, severe/unstable angina pectoris, symptomatic congestive heart failure, cerebrovascular accident, or pulmonary embolism. 6.Patients with a high suspicion of interstitial lung disease; or those who may interfere with the detection or management of suspected drug-related pulmonary toxicity. 7.Other active malignancies requiring concurrent treatment, including upper tract urothelial carcinoma. 8.Receipt of a live attenuated vaccine within 4 weeks prior to enrollment or planned during the study period. 9.Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 10.Patients with active pulmonary tuberculosis. 11.Patients who were previously excluded from any anti-PD-1 or anti-PD-L1 antibody clinical trial due to PD-L1 negative status. 12.Known history of a positive human immunodeficiency virus (HIV) test or known acquired immunodeficiency syndrome. 13.Untreated active hepatitis (Hepatitis B: HBsAg positive and HBV DNA >= 500 IU/mL; Hepatitis C: HCV RNA positive with abnormal liver function); co-infection with Hepatitis B and Hepatitis C. 14.Patients with peripheral neuropathy >= Grade 2. 15.Known allergy to PD-1 monoclonal antibodies/disitamab vedotin or their components. 16.History of severe allergic reactions to other monoclonal antibodies. 17.History of allergy or intolerance to infusions. 18.Judged by the investigator that the patient has other factors that may lead to premature termination of this study, such as other diseases or severe laboratory abnormalities, or family or social factors that may affect patient safety or the collection of trial data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The clinical complete response rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bladder Intact Disease-Free Survival;Event-Free Survival Rate;Overall Survival Rate; | — |
Countries
China
Contacts
Public ContactChen Junxing
The First Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed