Bladder cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: All enrolled subjects must meet all the following criteria: 1) Diagnosed unresectable local advanced or advanced bladder cancer; 2) Age not exceeding 75 years old; 3) ECOG score is 0-1; 4) Previously used a three cycle GC chemotherapy regimen, which was evaluated as SD by imaging, and it is not ruled out that ADC and immune checkpoint inhibitors have been used in combination; 5) After communication, subjects willing to participate in this study, promise to take the medication according to the doctor's advice, and can follow up and communicate on time.
Exclusion criteria
Exclusion criteria: Any candidate who meets any of the following criteria will not be eligible for inclusion in this study: 1) Any of the following states: people with immune deficiency or impairment (such as AIDS patients), who are using immunosuppressive drugs or radiotherapy; Individuals suffering from fever and acute infectious diseases, including active tuberculosis, or those undergoing anti tuberculosis treatment; Accompanied by severe chronic cardiovascular and cerebrovascular diseases or chronic kidney disease; 2) Merge with other tumors; 3) Known to have low immune function, acquired or congenital immunodeficiency, or a history of organ transplantation; 4) Individuals with severe cardiovascular and cerebrovascular diseases, such as myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accidents or transient ischemic attacks, or pulmonary embolism, who cannot tolerate TURBT surgery; 5) There are obvious main visceral organ dysfunction, such as creatinine is more than 2 times of the upper limit of the normal range, AST, ALT, total bilirubin are more than 2 times of the upper limit of the normal range, etc; 6) Subjects with fever and body temperature exceeding 38 ?, significant active infections that can affect clinical trials, such as acute pneumonia, active tuberculosis, and severe urinary tract infections; 7) Patients with diabetes who need to take sulfonylurea drugs and insulin for a long time; 8) Individuals who are allergic to the drug or its ingredients; 9) The researchers believe that there may be any situation that increases the risk of subjects or interferes with the execution of clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Overall Survival; | — |
Countries
China
Contacts
South China Hospital of Shenzhen University