Kidney Cancer
Conditions
Interventions
case series:None
Sponsors
Renji Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in the study, provide signed and dated written informed consent prior to any study specific procedures, sampling, and analysis, have good compliance, and cooperate with follow-up; 2. Aged 18-75 years, no gender limit; 3. The ECOG score is 0 or 1; 4. Expected survival > 3 months; 5. The subjects should be identified as advanced renal cancer patients with relevant evidence, and the researchers judged that the subjects should receive immunotherapy combined with targeted therapy; 6. Subjects not previously treated with immune checkpoint inhibitors, including CTLA-4 mab and PD-1/PD-L1 mab; 7. Major organ function is normal (14 days before enrollment), which means the following criteria are met: (1) Blood routine examination criteria should be met (no blood transfusion and no granulocyte colony-stimulating factor treatment within 14 days before enrollment) : 1) Leukocytes >=4x10^9/L; 2) Neutrophils >=2x10^9/L; 3) HB>=90 g/L; 4) ANC>=1.5x10^9 /L; 5) PLT>=100x10^9 /L; (2)Without functional organic disease, the following criteria must be met: 1) T-BIL 30ml/min (Cockcroft-Gault formula); 4) International Normalized ratio (INR), activated partial thromboplastin time (aPTT) : =60mL/min according to Cockcroft-Gault formula.
Exclusion criteria
Exclusion criteria: 1. Any activity or autoimmune disease patients with known history of autoimmune disease (with type I diabetes, due to autoimmune disease need hormone residues of hypothyroidism, does not require the system to treat psoriasis or in the absence of external trigger factors not expected recurrent cases, eligible to participate in the test). 2. Patients with adrenal insufficiency. 3. Patients with known HIV or known AIDS test positive. 4. Hepatitis B virus surface antigen or hepatitis C virus RNA test positive, indicating active or chronic infection. 5. Have received any non-tumor vaccine treatment for the prevention of infectious diseases, including seasonal (influenza) vaccine and COVID-19 vaccine, within 4 weeks. 6. Systemic hormone therapy and corticosteroid therapy should be stopped for 2 weeks. 7. Patients with malignant tumor activity in the past 3 years, except locally cured cancers such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast. 8. Treated with bone marrow stimulating factors, such as CSF (colony-stimulating factor) and EPO (erythropoietin) in the past 1 week; Has received live vaccine treatment in the past 4 weeks; Receiving allogeneic hematopoietic stem cell transplantation or solid organ transplantation; Has had major surgery (other than diagnostic surgery) in the past 4 weeks. 9. History of drug or psychotropic substance abuse. 10. In the opinion of the investigator, a known or underlying medical condition, such as a disease associated with diarrhea or acute diverticulitis, would make administration of the study drug dangerous to the patient or obscure the interpretation of toxicity tests or adverse events. 11. Investigator-determined history of clinically significant uncontrolled seizures, central nervous system disorders, or psychiatric disorders. 12. Deprivation of liberty or behavior modification or restraint.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor size;Plasma exosomal protein expression; | — |
Countries
China
Contacts
Public ContactZhai Wei
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed