urothelial cancer
Conditions
Interventions
Experimental group:tislelizumab plus gemcitabine
Sponsors
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18-80 years; 2.Pathologically confirmed urothelial carcinoma(evaluable lesions based on RECIST V1.1); 3.Cisplatin-ineligible patients, meet any of the followings: Level 2 hearing loss, Grade 2 peripheral neuropathy, Grade III heart failure according to the New York Heart Association classification, Creatinine clearance 30-60 mL/min, and ECOG PS=2; 4.No systemic chemotherapy or immunotherapy (platinum-based chemotherapy > 12 months are allowed to enroll); 5.Any PD-L1 state; Patients can undergo genetic testing for tumor tissue; 6.Estimated life expectancy > 3 months; the patient had indications for systemic treatment and had no contraindications; 7.The patient can understand and sign the informed consent (if the subject is incompetent, signed by his legal agent).
Exclusion criteria
Exclusion criteria: 1. Any history of active immunity or autoimmune disease; 2. Active infections that require systemic treatment; 3. Patients with any of the following uncontrolled cardiovascular diseases: (1) grade III or IV heart failure defined by the New York Heart Association (NYHA) functional grading system; (2) unstable angina pectoris; (3) myocardial infarction within the past one year; (4) Supra-ventricular or ventricular arrhythmias require treatment; (5) QTc interval >= 450 ms in men, >= 470 ms in women; 4. Treatment with systemic corticosteroids (> 10 mg/day prednisone or equivalent, excluding topical corticosteroids by nose spray or inhalation) or any other form of immunosuppressive therapy within 14 days prior to the first dose of study drug; 5. Patients with interstitial lung disease; 6. Patients have ever accepted any immuno-checkpoint inhibitors or any angiogenesis inhibitors; 7. Live vaccines within 4 weeks prior to or during the treatment.; 8. Pregnant or lactating women; 9. Known history of human immunodeficiency virus (HIV) infection; 10. Known active HBV or HCV infection; 11. Patients with a history of psychotropic substance abuse or mental disorders; 12. There are evidences of abnormal laboratory values, family or social factors, that may interfere with the trial, prevent the collections of data or sample, or threaten the safety of patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Overall Survival;Adverse Reactions;Quality of life; | — |
Countries
China
Contacts
Public ContactZhu Dongyuan
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Outcome results
None listed