Renal Cell Carcinoma
Conditions
Interventions
Interventional group 1:axitinib
Interventional group 2:Sintilimab
Interventional group 3:stereotactic body radiotherapy
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, aged 18-75; 2. ECOG 0-2 points; 3. Radical nephrectomy has been performed, and the postoperative pathological diagnosis is renal cell carcinoma; 4. Imaging diagnosis of local or regional recurrence, and no distant metastasis; 5. According to RECIST1.1 criteria, there is at least one evaluable lesion; 6. Expected life >= 3 months; 7. There is no obvious dysfunction of major organs (14 days before enrollment), that is, the following criteria are met: (1) The blood routine examination standards must meet: hemoglobin (HB) >=90g/L; neutrophils (ANC) >=1.5x10^9/L; platelets (PLT) >=100x10^9/L; (2) Non-functional organic diseases, the following criteria must be met: serum total bilirubin 1.5 ULN); alanine aminotransferase (ALT) and aspartate Transaminase (AST)=40ml/min and Cr>1.5xULN; urine protein =2+, 24-hour urine Protein must be <2g; International Normalized Ratio (INR), Activated Partial Thromboplastin Time (aPTT): <=1.5xULN; 8. Have not received systemic corticosteroid therapy for 7 days before treatment, except for physiological corticosteroid replacement therapy; 9. Males and females of childbearing age use highly effective contraceptive methods during the trial, and continue contraception for 12 months after the end of treatment; 10. Hepatitis B subjects who meet the following criteria can also be enrolled: HBV viral load <1000 copies/ml (200IU/ml) before enrollment, subjects should receive anti-HBV treatment during the entire study chemotherapy drug treatment to avoid virus Reactivation; for subjects with anti-HBc(+), HBsAg(-), anti-HBs(-), and HBV viral load(-), prophylactic anti-HBV therapy is not required, but viral reactivation needs to be closely monitored; 11. With my consent and signed informed consent, willing and able to comply with the planned visits, research treatments, laboratory examinations and other experimental procedures.
Exclusion criteria
Exclusion criteria: 1. Other malignant diseases (excluding basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection) within 5 years before enrollment; 2. Pregnant or lactating women; 3. History of allergy to any component of the study drug; 4. Currently enrolled in other interventional clinical research treatments, or received other research drug treatment within 4 weeks before enrollment; 5. Previously received axitinib + immune checkpoint inhibitor therapy for recurrent lesions (including anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibodies, etc.); 6. Received systemic systemic treatment of Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use for controlling pleural effusion) within 2 weeks before enrollment; 7. Active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, glucocorticoids or immunosuppressants) has occurred within 2 years before enrollment; 8. Within 7 days before enrollment, receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other local glucocorticoids) or immunosuppressive therapy, but allowing the use of physiological doses of glucocorticoids (<=10mg/ days of prednisone or equivalent); 9. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 10. Known history of human immunodeficiency virus (HIV) infection (ie HIV1/2 antibody positive); 11. Untreated active hepatitis B (defined as HBsAg positive and the number of HBV-DNA copies detected at the same time is greater than the upper limit of the normal value of the laboratory department of the research center); 12. Active HCV infected subjects (HCV antibody positive and HCV-RNA level higher than the detection limit); 13. Received live vaccine within 30 days before enrollment (cycle 1, day 1); allowed to receive inactivated virus vaccine for injection against seasonal influenza within 30 days before enrollment; but not allowed to receive live attenuated intranasal medication Flu vaccine; 14. The existence of any serious or uncontrolled systemic disease, such as: unstable angina pectoris, congestive heart failure of New York Heart Association (NYHA) class III-IV; any arterial disease within 6 months prior to enrollment Thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, etc.; history of non-infectious pneumonia requiring glucocorticoid therapy within 1 year before enrollment, or current Clinically active interstitial lung disease; active pulmonary tuberculosis; active or uncontrolled infection requiring systemic therapy; patients with mental disorders who cannot cooperate with treatment; 15. Received major surgical operations (craniotomy, thoracotomy or laparotomy) or unhealed wounds, ulcers or fractures within 2 weeks before enrollment; 16. The researcher believes that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;local control rate;Overall survival;Adverse events;Quality of life; | — |
Countries
China
Contacts
Public ContactHe Liru
Sun Yat-Sen University Cancer Center
Outcome results
None listed