Urothelial carcinoma
Conditions
Interventions
Immunotherapy combined with radiotherapy:Immunotherapy followed by radiotherapy
Sponsors
Yichang Central People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Age >= 18 years; 2) Histopathologically confirmed urothelial carcinoma; 3) Unsectable or metastatic urothelial carcinoma which is ameable to receive radiotherapy to all the tumors; no more two lines of previously chemotherapy for preciously treated patients; 4) Patient is willing and able to sign written informed consent; 5) Life expectancy > 3 months; 6) ECOG performance status of 0-1; 7) Adequate organ function: • Absolute neutrophil count >= 1.5*10^9/L; • Platelet count >= 100*10^9/L; • Hemoglobin >=90 g/L; • Blood creatinine = 30 mL/min; • Serum bilirubin <= 1.5*ULN; • Aspartate aminotransferase (AST) /alanine aminotransferase (ALT) <= 3ULN; • Institutional normalized ratio (INR) and activated partial thromboplastin time (aPTT) <= 1.5*ULN; 8) For female patients, pregnancy test must be negative; 9) Patients of childbearing/reproductive potential should agree to use effective birth control methods, during the study treatment period and for a period of at least 120 days after the last dose of immunotherapy; 10) Previously chemotherapy-related adverse events resolve to NCI CTCAE v5.0 <=1.
Exclusion criteria
Exclusion criteria: 1) Previously receive immune checkpoint inhibitors; 2) Previously receive radiotherapy to the tumors; 3) Previous history of inflammatory bowel disease or scleroderma; 4) Autoimmune conditions and need systemic treatment in the past 2 years; 5) Previous history of Guillain-Barre syndrome and Stevens-Johnson syndrome; 6) Active pneumonia and previous history of non-infectious pneumonitis; 7) Active infections requiring systemic therapeutic antibiotics; 8) Previous immunodeficiency disease or receive immunosuppressant like glucocorticoid; 9) Active tuberculosis; 10) Other active malignancy; 11) Other conditions which may interfere the explanation of the results, the process of the trial or not be the best interest of the patients; 12) Psychiatric disease or drug abuse which may interfere the trial study; 13) Previous history of HIV/AIDS infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DOR ;CBR;OS; | — |
Countries
China
Contacts
Public ContactJiayu Zhang
Yichang Central People's Hospital
Outcome results
None listed