Renal Pelvic and Ureteral Carcinoma
Conditions
Interventions
Systemic Therapy:No
RT + Systemic Therapy:No
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients who were histologically confirmed newly diagnosed or postoperatively metastatic upper tract urothelial carcinoma and are willing to receive systemic therapy (chemotherapy, immunotherapy, etc.). 2. Patient who is voluntarily agreed to participate in the study and signed the informed consent; Aged 18 or above. 3. ECOG physical strength score 0 or 1; Adequate heart, bone marrow and liver function: left ventricular ejection fraction =50%; Hemoglobin =9g/dL; Absolute neutrophil count (ANC) =1.5×109/L; Platelet =100 ×109/L; Serum total bilirubin =1.5 times the upper limit of normal value (ULN); ALT and AST were =2.5 × ULN in the absence of liver metastasis, and =5 × ULN in the presence of liver metastasis. 4. The subjects are not currently participating in or receiving any other investigational therapy. 5. There was no diagnosis of immunodeficiency, no systemic steroid therapy or any other form of immunosuppressive therapy, and no active tuberculosis during the 7 days prior to the first trial treatment.
Exclusion criteria
Exclusion criteria: 1. Previous history of tumors other than urothelial carcinoma; 2. Other medical history and complications affecting treatment, including the following: A. The subject has any active, known, or suspected autoimmune disease. Admitted subjects who are in a stable state and do not require systemic immunosuppressive therapy; B. Subjects requiring systemic therapy with corticosteroids (> 10 mg/ day of prednisone or equivalent) or other immunosuppressive agents within 14 days prior to study drug administration. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal hormone replacement at a dose > 10 mg/ day of prednisone efficacy dose are permitted; C. Antitumor vaccine or other immunostimulating antitumor therapy within the 3 months prior to administration of the study drug; D. Previous treatment with anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, or anti-CTLA-4 antibodies (or any other antibodies that act on the T-cell costimulation or checkpoint pathway); E. The patient is participating in another clinical study or less than 4 weeks after the end of the previous clinical study; F. Patients with a known or highly suspected history of interstitial pneumonia, or who may interfere with the detection or management of suspected drug-related pulmonary toxicity; G. Patients with active tuberculosis should be excluded; H. Severe acute or chronic infections requiring systemic treatment; I. Patients with heart failure (New York Heart Association standard Class III or IV), poor coronary artery disease control or arrhythmia, or a history of myocardial infarction in the 6 months prior to screening despite receiving appropriate medication; J. Live vaccination within 4 weeks prior to the administration of the study drug; inactivated virus vaccine administered injectable for seasonal influenza is allowed, but live attenuated influenza vaccine administered intranasally is not allowed; K. Patients with a history of chronic pancreatitis, or a history of heavy alcohol consumption, gallstones, severe hyperlipidemia and other high risk factors for pancreatitis should not be enrolled after strict evaluation; 3. Physical and laboratory findings, including the following: A. A known history of testing positive for human immunodeficiency virus (HIV) or a known history of acquired immunodeficiency syndrome (AIDS); B. untreated active hepatitis (hepatitis B: HBsAg positive with HBV DNA= 500 IU/mL; Hepatitis C: HCV RNA positive and abnormal liver function); Co-infection of hepatitis B and hepatitis C; 4. As determined by the investigator, the patient may have other factors that may force the study to be terminated, such as other serious diseases or serious abnormalities in laboratory tests or other factors that may affect the safety of the subjects, or family or social factors such as the collection of test data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse effect;objective remission rate;progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| cancer specific survival;overall survival; | — |
Countries
China
Contacts
Public ContactXianshu Gao
Outcome results
None listed