urothelium carcinoma
Conditions
Interventions
Single arm experiment:Use Tislelizumab single drug
Sponsors
Changhai Hospital Affiliated to Naval Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria 1) Male and female, 18-85 years old; 2) The transitional cells of patients with locally advanced (T4b, any N; or any T, N2-3) or metastatic (M1, IV) urothelial carcinoma (also known as urothelial TCC or UCC; including renal pelvis, ureter, and urethra) histologically confirmed as mixed tumor are the main histological types. Patients with locally advanced bladder cancer must have pelvic wall or adjacent organs involvement that cannot be removed surgically (T4b stage) or large lymph node metastasis (N2-N3). 3) The researchers determined that the patient was not suitable for platinum drug treatment or the first-line treatment failed with high expression of PD-L1. 4) The patient must have at least one measurable lesion, evaluated according to RECISTv1.1. 5) Local intravesical chemotherapy should be completed at least 4 weeks before the start of study treatment. 6) The patient's organ function is sufficient, which is measured by the following laboratory test values (obtained within 14 days before treatment) in the screening period: 1) Absolute neutrophil count (ANC) = 1.5 × 109 /L, platelet = 100 × 109 /L, hemoglobin = 90g /L, WBC count>2.5 × 109\/L Total serum bilirubin 1.5 × The upper limit of normal value (ULN) should be = 3 if Gilbert syndrome or indirect bilirubin concentration is shown as extrahepatic increase × ULN Aspartate, alanine aminotransferase and alkaline phosphatase (AST, ALT and AKP) 2.5 × ULN In case of liver metastasis, AST and /or ALT 5 × ULN If it is liver metastasis or bone metastasis, AKP5 × ULN 7) BMI requirement is between 18.5-24
Exclusion criteria
Exclusion criteria: Patients may be excluded from the study for any of the following reasons: 1) Previous treatment with PD-1 or PD-L1 as the target; 2) Any approved anticancer treatment, including hormone treatment, within 28 days before the start of the study and treatment; 3) History of severe allergic reaction to other monoclonal antibodies; 4) Uncontrolled hypercalcemia, defined as meeting one or more of the following criteria:>1.5mmol of ionic calcium; Serum calcium>3mmol /L; Corrected serum calcium>ULN (if serum albumin10mg/day or equivalent) or other immunosuppressive drugs is required. 17) Known left ventricular ejection fraction (LVEF)<40%; If the patients with coronary heart disease and congestive heart failure do not mee
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate;Disease control rate;1-year progression-free survival;2-year overall survival rate;Incidence rate of adverse events;Occurrence rate of serious adverse events; | — |
Countries
The People's Republic of China
Contacts
Public ContactXu, Chuanliang
Changhai Hospital Affiliated to Naval Military Medical University
Outcome results
None listed