Urothelial Carcinoma
Conditions
Interventions
ureter cancer group, bladder cancer group, renal pelvis cancer group and urethra cancer group:Sintilimab
Sponsors
The Second Hospital of Tianjin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be eligible for this study: 1. Patients diagnosed as myometrial infiltrative urothelial carcinoma or high-risk or non myometrial infiltrative urothelial carcinoma with BCG treatment failure or BCG intolerance; 2. Male or female aged 18-85 years; 3. The expected survival time was more than 12 weeks; 4. KPS score > 60, ECoG score is 0-2; 5. Organ function level must meet the following requirements: 6. Hematology indexes: neutrophil absolute count >= 1.5 x 10^9 / L, platelet count >= 80 x 10^9 / L, hemoglobin >= 6.0 g / dl (can be maintained by blood transfusion); 7. Liver function: total bilirubin = 60ml / min; 9. Be able to follow the research and follow-up procedures; 10. The patient has the ability to understand and sign the informed consent voluntarily.
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. The history of primary immunodeficiency is known. 4. We have known the history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 5. Pregnant or nursing female patients. 6. Untreated acute or chronic active hepatitis B or hepatitis C infection. Under the condition of monitoring the copy number of virus, the doctor will judge whether the patients who are receiving antiviral treatment are eligible for inclusion according to their individual conditions. 7. Uncontrolled concurrent diseases, including but not limited to: a) HIV infected (HIV antibody positive). b) Serious infection in active stage or poor clinical control. c) Evidence of serious 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., still greater than or equal to CTCAE Level 2 hypertension after drug treatment]). 8. Patients who have active bleeding or new thrombotic diseases are taking anticoagulants or have bleeding tendency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Imaging evaluation; | — |
Countries
China
Contacts
Public ContactHailong Hu
The Second Hospital of Tianjin Medical University
Outcome results
None listed