Advanced urothelial carcinoma
Conditions
Interventions
experimental group:Carrelizumab combined with gemcitabine
Sponsors
Zhujiang Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age between 18 and 75, no gender limitation; (2) ECOG PS score 0-2; (3) Pathology diagnosed ? period urothelial carcinoma (cancer stage according to the eighth edition of AJCC, 2017); (4) At least one measurable lesion (>= 10mm on spiral CT scan) according to RECIST1.1; (5) No systemic anti-tumor treatment received before phase IV urothelial carcinoma was diagnosed; (6) Patients who cannot tolerate platinum therapy with any of the following conditions: 1) Serum creatinine > 135µmol/L; 2) Serum urea > 7.1mmol/L; 3) glomerular filtration rate = 12 weeks; (8) The main organs should function normally and meet the following requirements: 1) Routine blood examination, should meet (no blood transfusion within 14 days): WBC >= 4.0 x 10^9/L; PLT >= 90 x 10^9 / L; Hb >= 80 g/L; 2) Blood biochemical test: TBil = 30 g/L; ALT and AST <= 3.0 x ULN; Cr <= 2.0 x ULN; TSH <= 1.0 x ULN. (9) Fertility female patients must have a pregnancy test (serum or urine) with negative results within 7 days prior to enrolment and voluntarily use appropriate methods of contraception during the observation period and within 8 weeks after the last dosing; (10) Voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Previous treatment with PD1/PDL1 monoclonal antibody; (2) Patients with any active autoimmune disease or a history of autoimmunity; (3) Diseases with concurrent use of immunosuppressive drugs;Disorder complicated by systemic or local absorbable corticosteroids requiring immunosuppressive doses.Prednisone dose greater than 10 mg/day or equivalent is prohibited for 2 weeks prior to study drug use; (4) Have a history of allergy to other antibody drugs; (5) A history of immunodeficiency or human immunodeficiency virus (HIV) infection; (6) Complicated with serious heart disease; (7) Kidney transplant patients; (8) Complicated with other malignant tumors; (9) Participated in other drug clinical trials within 3 months before medication; (10) The investigator does not consider it appropriate to participate in the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival, PFS;overall survival, OS;disease control rate, DCR;duration of relief, DCR;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactCao Manming
Zhujiang Hospital of Southern Medical University
Outcome results
None listed