urothelial carcinoma
Conditions
Interventions
experimental group:Sentilimab
Sponsors
Shandong Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years; 2. Recurrent metastatic urothelial carcinoma with measurable lesions confirmed histopathologically or histopathologically(meet RECIST1.1 standards); 3. Patients without immunotherapy; 4. Any PD-L1 status, patients can receive genetic testing of tumor tissue; 5. ECOGPS: 0-1 points; 6. Expected survival >= 3 months, the patient showed indications of systemic treatment and had no contraindications; 7. The patient can understand and sign the informed consent (in case of incapacity, the legal representative of the subject will sign on behalf of him).
Exclusion criteria
Exclusion criteria: 1. Subjects have any active autoimmune disease or a history of autoimmune disease; 2. Active infections requiring systemic treatment; 3. Clinical symptoms or diseases of the heart that are not well controlled, such as: (1) NYHA2 heart failure or above; (2) Unstable angina pectoris; (3) Myocardial infarction within 1 year; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (5) QTC >450ms (male);QTC >470ms (female); 4. Cortisol (greater than 10 mg/day prednisone or equivalent) or other systemic immunosuppressive agents (other than inhaled or topical corticosteroids) or prednisone or the equivalent of alternative therapies greater than 10 mg/day are required during the 14 days prior to study treatment; 5. Patients with prior and current objective evidence of interstitial lung disease; 6. Previous treatment with PD-1, PD-L1, CTLA-4 and other antibodies; 7. Live vaccine received less than 4 weeks before the study administration or possibly during the study period; 8. Pregnant or lactating women; 9. The known history of the human immunodeficiency virus (HIV); 10. Known active hepatitis B or C; 11. Persons with known mental illness or substance abuse disorders; 12. According to the researcher's judgment, the subjects may have other factors t hat may lead to the termination of the study. If there are serious abnormal laboratory tests, accompanied by family or social factors, it will affect the safety of the subjects or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Countries
China
Contacts
Public ContactZhu Dongyuan
Shandong Cancer Hospital
Outcome results
None listed