bladder cancer
Conditions
Interventions
sing-arm:PD-1 inhibitor, Gemcitabine and Cisplatin
Sponsors
The First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) male or female, aged >= 18 years, = 3.0 x 10^9/L;Neutrophil absolute count (ANC) >= 1.5 x 10^9/L;Platelets (PLT) >= 100 x 10^9/L;Hemoglobin (Hb) >= 9 g/dL; 5) blood biochemical test: AST (SGOT), ALT (SGPT) <= 2.5 x upper limit of normal value (ULN);Total bilirubin (TBIL) <= 2.5 x ULN; Serum creatinine (CRE) <= ULN; 6) coagulation function: prothrombin time (PT), INR <= 1.5 x ULN; 7) patients who have not received systemic chemotherapy or immunotherapy; 8) women of child-bearing age must be willing to use adequate contraception during research drug treatment; 9) informed consent has been signed.
Exclusion criteria
Exclusion criteria: 1) have received any prior systemic antitumor therapy; 2) systemic corticosteroids or other systemic immunosuppressive drugs were used within 2 weeks prior to treatment, and systemic immunosuppressive drugs were used or expected to be used during the trial.Inhaled corticosteroids, physiological replacement doses of glucocorticoids and mineral corticosteroids are permitted; 3) distant metastasis is known or suspected; 4) the patient has a history of autoimmune diseases; 5) serious uncontrolled systemic diseases, such as severe active infections; 6) known human immunodeficiency virus (HIV) infection or known HIV sero-positive; 7) have other malignant tumors in the past 5 years, except in situ cervical cancer or basal cell carcinoma of the skin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| pT<2;percentage of R0; | — |
Countries
China
Contacts
Public ContactBaiye Jin
The First Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed