| Eligibility |
Inclusion Criteria:
Patients who meet the following criteria are eligible to participate in the trial:
- Male or female aged 18 and = 75;
- Histologically or cytologically confirmed unresectable or metastatic clear cell
carcinoma of the kidney, which may contain sarcomatoid lesions;
- At least one measurable target lesion at the time of enrollment according to
RECIST1.1(Response Evaluation Criteria In Solid Tumors) standards;
- Tissue samples are available for testing;
- No previous systemic treatment for the disease;
- ECOG(Eastern Cooperative Oncology Group) PS(performance status) 0-1;
- Normal function of major organs (14 days prior to enrollment), i.e. meeting the
following criteria:
1. Blood routine examination criteria should be met (no blood transfusion and no
granulocyte colony were received within 14 days before enrollment Stimulator
therapy) :
HB 90 g/L or higher The ANC(absolute neutrophil count) acuity 1.5 x 109 / L
PLT(platelet count) acuity 100 x 109 / L
2. No functional organic disease, the following criteria should be met:
Serum creatinine (Cr) = 1.5× upper limit of normal (ULN) or creatinine clearance =40 mL/min
T-bil =1.5×ULN upper limit of normal value ALT(Alanine transaminase) and AST=2.5×ULN If
liver metastasis, ALT and AST=5×ULN
- Expected survival =3 months;
- Patients with potential fertility need to use contraception during the study period;
- Patients who volunteered to participate in this study and signed informed consent.
Exclusion Criteria:
Patients with any of the following conditions will be excluded from the trial:
1. Patients who have received the following medical interventions in the four weeks prior
to treatment:
- Radiation, surgery, chemotherapy, immunotherapy or molecular targeted therapy for
tumors
- To participate in other clinical studies of drug therapy
- Live attenuated vaccine history
2. Previously received PD-1/PD-L1 monoclonal antibody, CTLA-4 antibody(cytolytic T
lymphocyte-associated antigen) or other immunotherapy;
3. Previously received targeted therapy;
4. Definite brain/meningeal metastasis;
5. Patients who received systemic treatment with corticosteroids (> 10 mg daily
prednisone or equivalent) or other immunosuppressive drugs within 14 days prior to
enrollment;
6. Any active autoimmune disease or history of autoimmune disease (including but not
limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis,
hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism), or
known history of allogeneic organ transplantation or allogeneic hematopoietic stem
cell transplantation;
7. Severe disturbances (CTCAE, Common Terminology Criteria for Adverse Events> Class 2)
occurred within 4 weeks prior to administration of the study drug;Baseline chest
imaging suggests active pulmonary inflammation, signs and symptoms of infection
(unexplained fever >38.5 degrees) within 14 days prior to first use of the study drug,
or the need for oral or intravenous antibiotic treatment;
8. Patients with clinically significant bleeding symptoms or definite bleeding tendency
within 3 months prior to treatment, or with arteriovenous thrombosis events occurring
within 6 months prior to treatment;
9. Active cardiovascular disease, such as myocardial infarction, severe/unstable angina,
or New York Heart Association Class III or IV congestive heart failure, was present in
the 6 months prior to treatment.
10. Have had other malignancies in the past 5 years (basal cell carcinoma of the skin that
has been cured, except carcinoma in situ of the breast and carcinoma in situ of the
cervix);
11. Have multiple factors that affect oral medication (such as inability to swallow,
chronic diarrhea, and intestinal obstruction);
12. Known to have active tuberculosis;
13. HIV antibody positive, active hepatitis B or C (HBV, HCV);
14. Is known to be allergic to the investigational drug or any excipients thereof, or has
had a severe allergic reaction to other monoclonal antibodies;
15. Pregnant or lactating women and women of childbearing age do not take reliable
contraceptive measures;
16. In the investigator's judgment, there is a concomitant medical condition (such as
poorly controlled high blood pressure, severe diabetes, neurological or psychiatric
illness, etc.) or any other condition that seriously endangers the subject's safety,
may confuse the study results, or may interfere with the subject's completion of the
study.
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