Renal clear cell carcinoma
Conditions
Interventions
Experimental group:Tremelimumab
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with advanced renal cell carcinoma after surgical treatment and no radiographic tumor residue, who meet any of the following criteria: (pT2, grade 4 or sarcomatoid,N0,M0; pT3-T4,N0,M0; pTany,N+,MO; pTany Nany M1 oligometastatic renal cell carcinoma); 2.ECOG score: 0-1; 3. Hematological examination: i, neutrophil >=1.5*10^9/L; ii, platelet >=100*10^9/L; iii, hemoglobin >9.0g/dL; iv, serum creatinine =1.25*ULN or creatinine clearance (CrCl) >=50mL/min; v, AST/ALT=18 years old, both male and female; 5. No previous systemic therapy; 6. Underwent radical nephrectomy with negative surgical margins; 7. Female subjects of childbearing potential should have a urine or serum pregnancy test that proves negative within 72 hours before receiving the first dose of study drug and will need to use effective contraception during the study treatment period and for 3 months after the end of the study treatment period; Male patients who were not surgically sterilized or of reproductive age were required to consent to use effective contraception with their spouse during the study treatment period and for 3 months after the end of the study treatment period; 8. The subjects voluntarily participated in this study, with good compliance and cooperation in safety and survival follow-up.
Exclusion criteria
Exclusion criteria: Patients with any of the following could not be enrolled in the study 1. Prior radiotherapy, chemotherapy, long-term or high-dose hormonal therapy, or immune checkpoint inhibitors; (2) previous or concurrent history of other malignant tumors; 3. Previous treatment with other PD-1/PD-L1 inhibitors; Subjects were known to have a previous allergy to macromolecular protein preparations or to any PD-1 inhibitor component; 4. Have uncontrolled cardiac symptoms or diseases, such as: (1) heart failure of NYHA class 2 or above (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) presence Patients with supraventricular or ventricular arrhythmias of bed significance requiring treatment or intervention; 5. Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg>2g/L), bleeding tendency or receiving thrombolytic or anticoagulant therapy; 6. Have active infection requiring systemic treatment; 7. Patients with previous or current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe impairment of pulmonary function, etc.; 8. Known history of human immunodeficiency virus (HIV) infection; 9. Known active hepatitis B or hepatitis C virus infection; 10. Live vaccine administered less than 4 weeks before or possibly during the study administration; 11. According to the investigator's opinion, the subjects should be excluded from the study. For example, according to the investigator's judgment, the subjects have other factors that may lead to the forced termination of the study, such as other serious diseases (including mental diseases) requiring combined treatment, serious laboratory abnormalities, accompanied by family or social factors, which may affect the safety of the subjects, or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Overall Survival; | — |
Countries
China
Contacts
Public ContactGuodong Zhu
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed