Urothelial carcinoma
Conditions
Interventions
A:triplizumab combined with paclitaxel
B:triplizumab combined with paclitaxe
C:triplizumab combined with paclitaxe
D:triplizumab combined with paclitaxe
Sponsors
The Second Hospital of Tianjin Medical University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with myometrial invasive urothelial carcinoma or high-risk or non myometrial invasive urothelial carcinoma with failed BCG treatment or intolerable BCG; 2. Male or female aged 18-85; 3. The expected survival time is more than 12 weeks; 4. KPS function status score > 60, ECoG status score is 0-2; 5. Organ function level must meet the following requirements: 6. Hematological indexes: absolute neutrophil count = 1.5 × 109 / L, platelet count = 80 × 109 / L, hemoglobin = 6.0 g / dl (can be maintained by blood transfusion); 7. Liver function: total bilirubin = 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase = 2.5 times the upper limit of normal value, and intrahepatic aminotransferase = 5 times the upper limit of normal value if any; 8. Be able to follow the research and follow-up procedures; 9. The patient has the ability to understand and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Receive live attenuated vaccine within 4 weeks before enrollment or during the study period. 2. Active, known or suspected autoimmune diseases. 3. Known history of primary immunodeficiency. 4. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 5. Pregnant or lactating female patients. 6. Untreated acute or chronic active hepatitis B or hepatitis C infection. In the case of monitoring the number of virus copies of patients receiving antiviral treatment, the doctor will judge whether they are eligible for inclusion according to the individual situation of patients. 7. Uncontrolled concurrent diseases, including but not limited to: a) HIV infected persons (HIV antibody positive). b) Severe infection in active phase or poor clinical control. c) Evidence of severe or uncontrollable systemic diseases (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver or kidney diseases, uncontrolled hypertension [i.e. greater than or equal to CTCAE grade 2 hypertension after drug treatment]). d) Active bleeding or new thrombotic disease, taking therapeutic anticoagulants or bleeding tendency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the progression free survival of treprizumab combined with paclitaxel (albumin bound) in urothelial carcinoma; | — |
Countries
China
Contacts
Public ContactDawei Tian
Tianjin Huanghe Hospital
Outcome results
None listed