Urothelial carcinoma
Conditions
Interventions
experimental group: Chidamide plus Tislelizumab and chemotherapy
Sponsors
The General Hospital of the People's Liberation Army (PLAGH)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The age ranged from 18 to 75 years old; 2. Histologically or cytologically confirmed urothelial carcinoma of the renal pelvis, ureter, bladder or urethra (squamous differentiation or mixed type is allowed),unresectable locally advanced or metastatic urothelial carcinoma;; 3. There was no previous treatment for advanced diseases. If they have received neoadjuvant / adjuvant chemotherapy in the past, they should be at least 6 months away from the end of the last chemotherapy; 4. ECoG score was 0-1; 5. There was at least one measurable lesion (according to RECIST v1.1); 6. No Brain metastasis or asymptomatic Brain metastasis; 7. The absolute value of neutrophil >= 1.5 x 10^9 / L, platelet >= 100 x 10^9 / L, hemoglobin >= 90 g / L; 8. The expected survival time was more than 3 months; 9. During the screening period, tumor tissue samples were provided for detection of PD-L1 expression; 10. Volunteer to participate in this clinical trial and sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. No measurable lesions, such as pleural or pericardial effusion, ascites, etc.; 2. Major surgical procedures or obvious trauma were performed within 4 weeks before enrollment, or patients were expected recently to receive major surgical treatment; 3. Previous use of IL-2, TNF - a, or anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti cytotoxic T-lymphocyte associated antigen-4 (CTLA-4) antibodies (including apilimab or any other antibody or drugs specifically targeted at T-cell co stimulation or checkpoint pathway); 4. They have been treated with HDAC inhibitors (including Chidamide, Romidisin, vorinostat, belinostat, and panobinostat); 5. The patients received lung radiotherapy of > 30Gy within 6 months before enrollment; 6. There weremeningeal metastases or symptomatic brain metastases; 7. History of interstitial lung disease or pneumonia requiring oral or intravenous steroids; 8. Live vaccine has been or will be vaccinated within 30 days before the first study treatment (seasonal influenza vaccine without live vaccine is allowed); 9. Active infection (active bacteria, virus, fungus, Mycobacterium, parasitic infection or other infections (excluding nail bed fungal infection) within 4 weeks before screening period, or requiring intravenous antibiotic treatment or targeted antiviral treatment, or any major infection event in hospital), or persistent fever within 14 days before screening; 10. Have a history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 11. Significant cardiovascular diseases beyond control, history of clinically significant QT interval prolongation, or QTc interval > 450 ms in screening period; 12. Abnormal liver function (total bilirubin > 1.5 times of the upper limit of normal value; ALT / AST of patients without liver metastasis > 2.5 times of upper limit of normal value; ALT / AST of patients with liver metastasis > 5 times of upper limit of normal value), abnormal renal function (serum creatinine > 1.5 times of upper limit of normal value); 13. Pregnant, lactating or fertile women with a positive baseline pregnancy test; or subjects of childbearing age who are not willing to take effective contraceptive measures for at least 120 days (180 days after the last use of chemotherapy drugs) during the study period and after the last use of the study drug, whether male or female; 14. According to the judgment of the researcher, there are some concomitant diseases (such as severe hypertension, diabetes, thyroid disease, active infection, etc.) that seriously endanger the safety of patients or affect patients to complete the study; 15. Have a clear history of neurological or mental disorders, including epilepsy or dementia; 16. The researcher determined that it was not suitable to participate in the study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Primary
| Measure | Time frame |
|---|---|
| objective overall survival; | — |
Countries
China
Contacts
Public ContactYi Hu
The PLA General Hospital
Outcome results
None listed